SOMATOM X.cite 11330001 (UDI 04056869231044)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04056869231044), received between Apr 19, 2021 and Dec 11, 2025 — classified as 1 death, 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (3 reports).

2 FDA recall records name this device's identifier, 2 still open.

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 16, 2026.

Recalls naming this device

1. Dec 22, 2022Open, Classified

   In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation labels head , center, and feet in the axial thick slice segments are erroneously swapped

   Z-1003-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Mar 7, 2022Open, Classified

   Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software errors may also occur during interventional workflows. Results in potential patient issues: Possible rescan , Unexpected X-Ray dose and additional contrast media, Delay in diagnosis, scan abort,and patient rescan

   Z-0962-2022 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM X.CITE CT SCANNER. THE CUSTOMER REPORTED DIFFICULTIES INITIALIZING A PRE-MONITORING SCAN FOR A STROKE PROTOCOL. THE PATIENT WAS SAFELY REMOVED FROM THE SYSTEM AND TRANSFERRED TO AN ALTERNATE SYSTEM WHERE THE SCAN WAS COMPLETED. A DELAY OF APPROXIMATELY 20 MINUTES OCCURRED, AND THE TOPOGRAM HAD TO BE REPEATED. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778438 ↗
• MalfunctionDec 8, 2025Unintended Movement; Unintended Movement

  ON NOVEMBER 24, 2025, SIEMENS HEALTHINEERS WAS NOTIFIED OF A TECHNICAL ISSUE INVOLVING A SOMATOM X.CITE CT SYSTEM LOCATED IN THE UNITED STATES. THE CUSTOMER REPORTED THAT THE SYSTEM¿S PATIENT TABLE WAS ¿MOVING ON ITS OWN WITHOUT ANY BUTTONS BEING PRESSED.¿ AT THIS TIME, THERE HAVE BEEN NO REPORTS OF ADVERSE HEALTH EFFECTS RELATED TO THIS ISSUE. WE ARE SUBMITTING THIS REPORT OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744101 ↗
• MalfunctionSep 15, 2025Mechanical Problem; Unintended Movement; Mechanical Problem; Unintended Movement

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM X.CITE CT SCANNER. DURING PATIENT POSITIONING FOR A THORAX/ABDOMEN SCAN, THE USER REPORTED THAT WHILE MOVING THE TABLE WITH A PATIENT ON IT INTO THE GANTRY, THE TABLE KEPT MOVING AFTER HAVING RELEASED THE ¿MOVE¿ BUTTON. ONCE THE TABLE MOVED TO THE END-POSITION, THE BUTTONS ON THE LEFT GANTRY PANEL BECAME UNRESPONSIVE. AFTER PRESSING THE EMERGENCY STOP BUTTON AND CLICKING ¿OK¿ ON THE CONTROL BOX THE SCAN COULD BE FINISHED AS PLANNED. FOLLOWING THE SCAN, THE SYSTEM WAS SHUT DOWN, RESTARTED AND SHOWED ERROR MESSAGES. NO PATIENT INJURY OR ADVERSE HEALTH CONSEQUENCES WERE REPORTED AS A RESULT OF THIS EVENT, AND A RESCAN WAS NOT REQUIRED. THIS INCIDENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION. THE INCIDENT IS CURRENTLY UNDER COMPREHENSIVE INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED UPON ITS CONCLUSION, AND ANY NEW, RELEVANT INFORMATION WILL BE REPORTED AS IT BECOMES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23049125 ↗
• MalfunctionApr 25, 2025Output Problem; Output Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM X.CITE CT SCANNER. THE CUSTOMER REPORTED THAT DURING THE PERFUSION SCAN OF A 60-YEAR-OLD, FEMALE PATIENT, HE HAD ISSUES PROCESSING THE DATA. THE PATIENT UNDERWENT A THREE-PART EXAMINATION CONSISTING OF A NON-CONTRAST HEAD CT, PERFUSION IMAGING, AND CERVICAL ARTERY IMAGING. WHILE PERFUSION MAPS WERE BEING PROCESSED, THE NECESSARY DIAGNOSES WERE ALREADY MADE FROM THE CERVICAL ARTERY IMAGES. THEREFORE, REPEATING THE PERFUSION SCAN WAS UNNECESSARY. THE CUSTOMER REPORTED A DELAY IN DIAGNOSIS OF APPROXIMATELY 15 MINUTES WHICH DID NOT CAUSE ANY NEGATIVE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21908197 ↗
• InjuryMay 24, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM X.CITE CT SYSTEM. ON (B)(6) 2024, AN 88-YEAR-OLD FEMALE PATIENT WITH DEMENTIA WAS ON THE CT SCANNER FOR AN ABDOMEN SCAN. THE PATIENT WAS POSITIONED HEADFIRST WITH ARMS AT HER SIDES. AFTER THE SCAN, WHEN THE PATIENT WAS ALREADY OFF THE TABLE, THE PATIENT COMPLAINED ABOUT PAIN IN HER LEFT THUMB. THE HOSPITAL STAFF CHECKED THE THUMB AND NOTICED A DEEP LACERATION. THE PATIENT WAS SENT TO THE WARD FOR FURTHER TREATMENT. LATER, THE HOSPITAL STAFF OBSERVED A PIECE OF THE PATIENT¿S THUMB ON THE FLOOR NEXT TO THE CT SCANNER. THE AMPUTATED PORTION OF THE THUMB WAS CUT OFF BELOW THE NAIL BED INCLUDING THE WHOLE NAIL AND PHALANX. REATTACHMENT WAS NOT POSSIBLE BECAUSE OF THE CONDITION OF THE TISSUES.

  Patient problems: Laceration(s)

  MAUDE report 19392766 ↗
• MalfunctionMar 31, 2023Computer Software Problem; Computer Software Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM X.CITE CT SYSTEM. A CUSTOMER REPORTED AN ISSUE WHILE USING THE MYNEEDLE GUIDE CT INTERVENTION APPLICATION ON (B)(6) 2023. THE IMAGE ORIENTATION WAS FLIPPED WHEN THE CUSTOMER ATTEMPTED TO MIRROR THE IMAGING USING A NON-DEFAULT POSITION. THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF ANY PATIENT OR USER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16654357 ↗
• InjuryDec 12, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM X.CITE CT SYSTEM. IT WAS REPORTED THAT A PATIENT'S (70 YEARS OLD, MALE) ARM WAS TRAPPED IN THE PATIENT TABLE ON (B)(6),2022. ACCORDING TO THE CUSTOMER, THE PATIENT WAS LYING HEAD FIRST AND FACE DOWN. AFTER THE SCAN, WHEN THE TABLE MOVED OUT, THE SKIN OF THE PATIENT'S ARM WAS PINCHED BETWEEN THE TABLE AND THE TABLE TOP. AN APPROXIMATELY 4-5 CM HEMATOMA FORMED, WHICH WAS TREATED WITH HYDROSALVE. NO OTHER INJURIES WERE REPORTED. THEREFORE, THIS REPORT HAS BEEN SUBMITTED WITH AN ABUNDANCE OF CAUTION.

  Patient problems: Hematoma

  MAUDE report 15959755 ↗
• DeathMay 24, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED TO SIEMENS THAT DURING THE CT EXAMINATION OF AN UNSTABLE, CRITICAL PATIENT, THE PATIENT NEEDED A CPR (CARDIOPULMONARY RESUSCITATION), THE PATIENT TABLE SHEET AND SOME EQUIPMENT CABLES GOT STUCK IN THE SLIT BETWEEN THE TABLE AND TABLETOP, SO THE PATIENT COULD NOT BE PULLED OUT OF THE GANTRY FOR CPR UNTIL STAFF MEMBER CUT THE SHEET AND THE CABLES IN ORDER TO RELEASE HIM. THE DELAY WAS REPORTED AS "A FEW MINUTES". DUE THE PATIENT'S MEDICAL HISTORY, THE FAMILY DECIDED THAT THE PATIENT SHOULD NOT BE RESUSCITATED ("DNR"). THE PATIENT UNFORTUNATELY PASSED AWAY FOLLOWING SEPTIC SHOCK. THIS WAS NOT A RESULT OF THE DELAY IN CPR IN THE CT ROOM. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: Sepsis

  MAUDE report 14489605 ↗
• MalfunctionMar 8, 2022Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED TO SIEMENS THAT THE CT SCAN ABORTED DURING A NON-CONTRAST CHEST EXAMINATION OF A (B)(6) PATIENT. THE USER RESCANNED THE PATIENT USING A DIFFERENT SCANNER AND COMPLETED THE EXAMINATION. OTHER THAN THE ADDITIONAL X-RAY DOSE DUE TO THE SECOND SCAN, NO PATIENT INJURY WAS REPORTED TO SIEMENS ASSOCIATED WITH THE REPORTED EVENT. THIS REPORT HAS BEEN SUBMITTED WITH AN ABUNDANCE OF CAUTION. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13693803 ↗
• InjuryAug 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO SIEMENS THAT A MODERATE PATIENT INJURY OCCURRED AT THE END OF THE CT EXAMINATION. DURING PATIENT UNLOADING FROM THE SCANNER AFTER THE COMPLETION THE EXAMINATION, THE PATIENT'S FINGER GOT CAUGHT IN THE "PINCH ZONE" OF THE PATIENT TABLE, AND AN AVULSION INJURY TO THE SKIN OF THE PATIENT'S FIFTH DISTAL DIGIT RESULTED. THE PATIENT WAS RESPONDING TO COMMANDS FROM THE FACILITY STAFF UP UNTIL THE TIME OF THE INCIDENT. THERE WAS NO REPORT OF A DEVICE MALFUNCTION. THE PATIENT'S WOUND WAS CLEANED AND BANDAGED AT THE FACILITY. ADDITIONAL TREATMENT INCLUDED CONSERVATIVE MANAGEMENT OF THE WOUND AND OBSERVANCE FOR SIGNS OF INFECTION FOR A WEEK. THE PATIENT CONTINUES WITH WEEKLY APPOINTMENTS AT THE ORTHOPEDIC OFFICE. ADDITIONAL NEGATIVE HEALTH CONSEQUENCES TO THE PATIENT WERE NOT REPORTED TO SIEMENS. THIS REPORT HAS BEEN FILED WITH AN ABUNDANCE OF CAUTION.

  Patient problems: Laceration(s)

  MAUDE report 12365476 ↗
• InjuryApr 19, 2021Use of Device Problem; Use of Device Problem

  IT WAS INITIALLY REPORTED TO SIEMENS THAT THE PATIENT SUSTAINED A LARGE SKIN TEAR AND BRUISING ON THE UPPER ARM DURING AN EXAMINATION WITH THE SOMATOM X.CITE SYSTEM. ADDITIONAL REPORTED INFORMATION FROM THE FACILITY RADIOLOGIST AND NURSE, STATED THAT THE PATIENT WAS TREATED ONLY WITH ICEPACKS AND PANADOL FOR PAIN. THE PATIENT'S HEALTH STATUS WAS RETURNED TO THE LEVEL IT WAS BEFORE THE INCIDENT. THEREFORE, IT IS UNLIKELY THE PATIENT SUSTAINED AN OPEN SKIN TEAR WOUND, SINCE SUCH AN INJURY WOULD REQUIRE ADDITIONAL TREATMENT. THE PATIENT INJURY OCCURRED WHILE LAYING PRONE ON THE PATIENT TABLE WHEN THEIR UPPER ARM WAS CAUGHT IN THE TABLE RUNNER DURING REMOVAL FROM THE GANTRY. NO STRAPS WERE USED TO SECURE THE PATIENT DURING THE EXAMINATION. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: Bruise/Contusion

  MAUDE report 11691249 ↗