Artis zee multi-purpose 10094139Recalls & reported problems
Siemens Healthcare GmbH · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Siemens Artis zee imaging system is an X-ray system used to guide procedures. Reports describe mechanical and electrical problems, unexpected radiation, and equipment movement or parts coming loose. There are 26 reports, with no deaths and 1 injury. All 3 recalls are open: they concern low coolant that can overheat the X-ray tube and software problems that can prevent the system from starting normally.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 04056869010076), received between Jun 18, 2020 and Apr 29, 2024 — classified as 1 injury, 25 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).
3 FDA recall records name this device's identifier, 3 still open.
68 other recalls cover devices cleared under the same FDA submission (K122644, K141574, K181407); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Mar 21, 2024Class IIOpen, Classified
Coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message TUBE HOT, have a break . the system cannot be operated normally, may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system
Z-1598-2024 · Root cause: Device Design · Recall details · FDA record ↗
- Dec 16, 2022Class IIOpen, Classified
In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach full operating mode. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system.
Z-1040-2023 · Root cause: Software design · Recall details · FDA record ↗
- Feb 23, 2022Class IIOpen, Classified
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".
Z-0969-2022 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component3
- Electrical /Electronic Property Problem3
- Mechanical Problem3
- Computer Software Problem2
- Insufficient Device Problem Information2
- Output Problem2
- Radiation Output Failure2
- Unexpected/Unintended Radiation Output2
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- No Known Impact Or Consequence To Patient5
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE ARTIS ZEE MULTI-PURPOSE SYSTEM. THE LONGITUDINAL DRIVE SPINDLE FOR THE C-ARM MOVEMENT BROKE OFF WHILE THE UNIT WAS TILTED TO A 90-DEGREE POSITION. THE C-ARM ASSEMBLY DID NOT COMPLETELY FALL ONTO THE GROUND AS IT WAS CAUGHT BY THE TABLE ARM CARRIAGE. THE NEARBY TROLLEY WAS DAMAGED AS WELL. ADDITIONAL INFORMATION WAS PROVIDED THAT NO PATIENT WAS ON THE TABLE. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF ANY PERSONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19202863 ↗MalfunctionJan 22, 2024Unintended Collision; Unintended Collision
IT WAS REPORTED TO SIEMENS THAT AN INCIDENT OCCURRED THAT INVOLVED THE ARTIS ZEE MULTI-PURPOSE SYSTEM. PRIOR TO THE START OF A PATIENT PROCEDURE, A COLLISION DUE TO AN INTENDED SYSTEM MOVEMENT OCCURRED. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT. SIEMENS HAS REQUESTED ADDITIONAL DETAILS IN ORDER TO CONDUCT AN INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18551789 ↗MalfunctionJan 8, 2024Radiation Output Failure; Radiation Output Failure
SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE MULTI-PURPOSE SYSTEM. DURING AN EMERGENCY PROCEDURE, THE USER EXPERIENCED SPORADIC ISSUES WITH X-RAY RELEASE. THE PATIENT WAS RELOCATED TO ANOTHER HOSPITAL TO COMPLETE THE MEDICAL PROCEDURE ON AN ALTERNATE UNIT. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18466503 ↗MalfunctionJan 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE ARTIS ZEE MULTI-PURPOSE SYSTEM. THE USER REPORTED THAT THE FOOTBOARD SLIPPED OUT OF THE ENGAGED POSITION WHILE A PATIENT WAS STEPPING ON IT. THE FOOTBOARD SLIPPED AND MOVED DOWN SLIGHTLY ON THE PATIENT LEFT SIDE. ACCORDING TO THE USER, THE FOOTBOARD WAS TESTED AFTER INSTALLATION TO ENSURE SECURE FITTING AND PINS ENGAGEMENT. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18426627 ↗MalfunctionSep 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED ON THE ARTIS ZEE MULTI-PURPOSE SYSTEM. ACCORDING TO THE INFORMATION PROVIDED BY THE USER, THERE WAS A WATER LEAK IN THE EXAM ROOM THAT WAS AFFECTING THE MACHINE. THE MACHINE GAVE AN ELECTRIC SHOCK WHEN THE USER PRESSED THE BUTTON. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PERSON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17824207 ↗MalfunctionJul 18, 2023Defective Component; Unexpected/Unintended Radiation Output; Defective Component; Unexpected/Unintended Radiation Output
SIEMENS SERVICE ORGANIZATION REPORTED THAT FLUORO RADIATION VALUES DURING CONSTANCY CHECK ON THE ARTIS ZEE MULTI-PURPOSE SYSTEM WERE TOO HIGH. HIGHER RADIATION DOSE WAS DETECTED DURING TESTING DUE TO A DEFECTIVE FOCUS. DETAILED CLARIFICATIONS OF THIS EVENT ARE CURRENTLY ONGOING; THEREFORE, THE EVENT IS REPORTED IN DOUBT. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17343695 ↗InjuryDec 6, 2022Output Problem; Unexpected/Unintended Radiation Output; Output Problem; Unexpected/Unintended Radiation Output
IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED THAT INVOLVED THE ARTIS ZEE MULTI-PURPOSE SYSTEM. ACCORDING TO THE USER, THE RADIATION (FLUORO) ON THE SYSTEM WAS ACTIVE FOR ABOUT 40 MINUTES DUE TO A CHAIR THAT HAD BEEN ACCIDENTLY PUT ON THE FOOT PEDAL UNDER THE TABLE IN THE CONTROL ROOM BY HOSPITAL PERSONNEL. ONE PERSON FROM CLEANING DEPARTMENT WAS EXPOSED TO SCATTERED RADIATION FOR SEVERAL MINUTES. THERE WAS NO IMPACT TO THE STATE OF HEALTH OF THE PERSON INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL DETAILS IN ORDER TO CONDUCT AN INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15923833 ↗MalfunctionDec 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE MULTI-PURPOSE SYSTEM. DURING A PROCEDURE, THE DISPLAY CEILING SUSPENSION WAS HOLDING FOR AT LEAST 10 MINUTES AND THEN BEGAN TO MOVE DOWN BY ITSELF. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13042118 ↗MalfunctionSep 2, 2021Output Problem; Output Problem
IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE MP SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE SYSTEM WENT INTO BYPASS MODE. THE PROCEDURE WAS CONTINUED AND COMPLETED ON AN ALTERNATE SYSTEM. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12413670 ↗MalfunctionAug 20, 2021Radiation Output Failure; Radiation Output Failure
IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE MULTI-PURPOSE SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE SYSTEM STOPPED FLUORO AND ACQUISITION. THE PROCEDURE WAS CONTINUED AND COMPLETED ON AN ALTERNATE SYSTEM. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12347749 ↗MalfunctionJun 28, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE MULTI-PURPOSE SYSTEM. THE USER REPORTED THAT A SYSTEM COLLISION OCCURRED WHILE TRANSITIONING THE STAND FROM 0 DEGREES TO A 90 DEGREE POSITION. THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF ANY PATIENT OR USER INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12074844 ↗MalfunctionJun 2, 2021No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE MULTI-PURPOSE SYSTEM. DURING A PROCEDURE, THE USER REPORTED THAT THE DOSE LEVEL ADMINISTERED WAS ABOVE A CERTAIN DOSE LEVEL. AT THIS TIME, THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF ANY PATIENT OR USER INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11919235 ↗MalfunctionMay 10, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WITH THE ARTIS ZEE MULTI-PURPOSE SYSTEM. IT WAS REPORTED THAT SMOKE WAS COMING FROM THE TECHNICAL ROOM AND A FIRE BRIGADE INTERVENTION OCCURRED. NO FIRE WAS DETECTED AND INFORMATION WAS PROVIDED THAT THE SYSTEM WAS NOT IN USE AT THE TIME OF THE EVENT. THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF ANY PATIENT OR USER INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11796478 ↗MalfunctionApr 21, 2021Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE MULTI-PURPOSE SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE IMAGE ACQUISITION SYSTEM (IAS) CRASHED DURING FLUOROSCOPY. THE PROCEDURE WAS CONTINUED AND COMPLETED ON AN ALTERNATE SYSTEM. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11699430 ↗MalfunctionMar 29, 2021Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE MULTI-PURPOSE SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE C-ARM WAS STUCK IN THE LATERAL POSITION. THE PROCEDURE WAS CONTINUED AND COMPLETED ON AN ALTERNATE SYSTEM. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11581894 ↗MalfunctionMar 12, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE MULTI-PURPOSE SYSTEM. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED THAT THE LIVE MONITOR SHOWS NO IMAGE. THE PROCEDURE WAS CONTINUED AND COMPLETED ON AN ALTERNATE SYSTEM. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11472619 ↗MalfunctionMar 11, 2021Computer Software Problem; Computer Software Problem
IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE MULTI-PURPOSE SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT WHEN STEPPING ON FLUORO TO ACQUIRE A NEW IMAGE, A PREVIOUS IMAGE WAS REPLAYED. IT WAS REPORTED THAT ONE SCENE OF A PREVIOUS PATIENT WAS ADDED TO THE BEGINNING OF ANOTHER PATIENT. THE PROCEDURE WAS CONTINUED AND COMPLETED ON AN ALTERNATE SYSTEM. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11461278 ↗MalfunctionJan 13, 2021Use of Device Problem; Use of Device Problem
IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE MULTI-PURPOSE SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT NO X-RAY WAS POSSIBLE. THE PROCEDURE WAS CONTINUED AND COMPLETED ON AN ALTERNATE SYSTEM. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11164633 ↗MalfunctionDec 16, 2020Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO SIEMENS THAT DURING AN INTERVENTIONAL PROCEDURE USING THE REPORTED ARTIS ZEE SYSTEM C-ARM WAS COLLIDING WITH THE FLOOR AND THE BLACK COLLISION STRIPS WERE NOT WORKING. THE PROCEDURE WAS CONTINUED AND FINISHED USING AN ALTERNATIVE SYSTEM. THERE WAS NO REPORT OF ADVERSE EFFECT TO THE HEALTH STATUS OF THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11024009 ↗MalfunctionNov 16, 2020Patient Data Problem; Patient Data Problem
IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE MULTI-PURPOSE SYSTEM. THE USER REPORTED THAT THE SYSTEM USED AN IMAGE FROM A PREVIOUS PATIENT TO CREATE THE ROADMAP IMAGE. AT THIS TIME THERE IS NO REPORT OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10842484 ↗MalfunctionOct 7, 2020Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE MULTI-PURPOSE SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT NO SYSTEM MOVEMENT WAS POSSIBLE. THE PROCEDURE WAS CONTINUED AND COMPLETED ON AN ALTERNATE SYSTEM. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10641742 ↗MalfunctionAug 19, 2020Use of Device Problem; Use of Device Problem
IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE MULTI-PURPOSE SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED DARK IMAGES. THE PROCEDURE WAS CONTINUED AND COMPLETED ON AN ALTERNATE SYSTEM. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10424621 ↗MalfunctionJul 24, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED TO SIEMENS THAT AN ERROR OCCURRED WHILE USING THE ARTIS ZEE MULTI-PURPOSE SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTS LIMITED STAND/TABLE MOVEMENT. THE PROCEDURE WAS CONTINUED AND FINISHED USING AN ALTERNATE SYSTEM. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO INVESTIGATE OF THE REPORTED EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10321154 ↗MalfunctionJul 17, 2020Computer Software Problem; Computer Software Problem
IT WAS REPORTED TO SIEMENS THAT AN ERROR OCCURRED WHILE USING THE ARTIS ZEE MULTI-PURPOSE SYSTEM. THE USER REPORTS SPORADICAL UNINTENDED TABLE MOVEMENT. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO INVESTIGATE THE REPORTED EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10289416 ↗MalfunctionJun 24, 2020Power Problem; Power Problem
IT WAS REPORTED TO SIEMENS THAT AN ERROR OCCURRED WHILE USING THE ARTIS ZEE MULTI-PURPOSE. DURING AN EMERGENCY PROCEDURE, THE USER REPORTS NO X-RAY POSSIBLE SPORADICALLY. THE PROCEDURE WAS CONTINUED AND FINISHED USING AN ALTERNATE SYSTEM. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO INVESTIGATE OF THE REPORTED EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10190356 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K122644, K141574, K181407. One submission often covers many models, so check the product and lot details in each record.
- Z-1645-2022 · Aug 10, 2022 · Open, ClassifiedArtis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Ar
- Z-1343-2022 · May 24, 2022 · TerminatedArtis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System
- Z-0967-2022 · Feb 23, 2022 · Open, ClassifiedArtis zee floor, Model Number 10094135
- Z-0977-2022 · Feb 23, 2022 · Open, ClassifiedArtis Q zeego, Model Number 10848283
- Z-0976-2022 · Feb 23, 2022 · Open, ClassifiedArtis Q biplane, Model Number 10848282
- Z-0975-2022 · Feb 23, 2022 · Open, ClassifiedArtis Q ceiling, Model Number 10848281
- Z-0973-2022 · Feb 23, 2022 · Open, ClassifiedArtis zeego, Model Number 10280959
- Z-0974-2022 · Feb 23, 2022 · Open, ClassifiedArtis Q floor, Model Number 10848280
- Z-0980-2022 · Feb 23, 2022 · Open, ClassifiedArtis Q.zen biplane, Model Number 10848355
- Z-0968-2022 · Feb 23, 2022 · Open, ClassifiedArtis zee ceiling, Model Number 10094137
- Z-0972-2022 · Feb 23, 2022 · Open, ClassifiedArtis zee biplane MN, Model Number 10094143
- Z-0978-2022 · Feb 23, 2022 · Open, ClassifiedArtis Q.zen floor, Model Number 10848353
- Z-0971-2022 · Feb 23, 2022 · Open, ClassifiedArtis zee floor MN, Model Number 10094142
- Z-0979-2022 · Feb 23, 2022 · Open, ClassifiedArtis Q.zen ceiling, Model Number 10848354
- Z-0970-2022 · Feb 23, 2022 · Open, ClassifiedArtis zee biplane, Model Number 10094141
…and 53 more.
Other System, x-ray, tomography, computed devices
- ARTIS icono biplane 11327600Siemens Healthcare GmbH · System, x-ray, tomography, computed15 recalls2 deaths55 reports
- ARTIS icono floor 11327700Siemens Healthcare GmbH · System, x-ray, tomography, computed15 recalls24 reports
- Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · System, x-ray, tomography, computed13 recalls5 reports
- Spectral CTPhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed11 recalls3 reports
- Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · System, X-Ray, Tomography, Computed9 recalls20 reports
- Brilliance iCTPhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed8 recalls6 reports
- Revolution Apex EliteGE Medical Systems, L.L.C. · System, x-ray, tomography, computed8 recalls0 reports
- Brilliance CT Big BorePhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed7 recalls1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page