Artis Q.zen biplane 10848355Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04056869010038), received between Sep 20, 2021 and Sep 29, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (2 reports).

4 FDA recall records name this device's identifier, 4 still open.

86 other recalls cover devices cleared under the same FDA submission (K123529, 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.

Recalls naming this device

1. 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 ↗

2. 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 ↗

3. Aug 10, 2022Class IIOpen, Classified

   Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.

   Z-1645-2022 · Root cause: Device Design · Recall details · FDA record ↗

4. 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-0980-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2022Unintended Collision; Radiation Output Problem; Unintended Collision; Radiation Output Problem

  IT WAS REPORTED TO SIEMENS THAT AN INCIDENT OCCURRED WHILE OPERATING THE ARTIS Q.ZEN BIPLANE SYSTEM. THE CUSTOMER REPORTED COLLISION OF THE SIDE ARMS. DURING THE COLLISION THE SIDE ARM BENT THE RADIATION FILED. SIEMENS IS UNAWARE OF ANY PERSONNEL OR PATIENT INVOLVEMENT. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT. THE REPORTED EVENT OCCURRED IN JAPAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15502469 ↗
• MalfunctionApr 25, 2022Radiation Overexposure; Radiation Overexposure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q.ZEN BIPLANE SYSTEM. THE CUSTOMER REPORTED A SUBSTANTIALLY HIGHER DOSE TO A PEDIATRIC PATIENT. 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 14191928 ↗
• MalfunctionApr 13, 2022Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q.ZEN BIPLANE SYSTEM. DURING A PROCEDURE, THE USER REPORTED THAT X-RAY WAS NOT AVAILABLE. 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 14101111 ↗
• MalfunctionOct 11, 2021Computer Software Problem; Computer Software Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q.ZEN BIPLANE SYSTEM. DURING A CARDIOBAND-VALVE RECONSTRUCTION, UNDER GENERAL ANESTHESIA, THE USER REPORTED THAT THE X-RAY SYSTEM FAILED. IT WAS REPORTED THAT A SOFTWARE PATCH WAS INSTALLED WITHOUT EXTERNAL INFLUENCE. THE PROCEDURE WAS NOT ABLE TO BE CONTINUED. 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 12611582 ↗
• MalfunctionSep 20, 2021Computer Software Problem; Computer Software Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q.ZEN BIPLANE SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT NO X-RAY WAS POSSIBLE. THE PROCEDURE WAS NOT CONTINUED. 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 12494667 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123529, K181407. One submission often covers many models, so check the product and lot details in each record.

• Z-1343-2022 · May 24, 2022 · Terminated
  Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System
• Z-0974-2022 · Feb 23, 2022 · Open, Classified
  Artis Q floor, Model Number 10848280
• Z-0971-2022 · Feb 23, 2022 · Open, Classified
  Artis zee floor MN, Model Number 10094142
• Z-0972-2022 · Feb 23, 2022 · Open, Classified
  Artis zee biplane MN, Model Number 10094143
• Z-0978-2022 · Feb 23, 2022 · Open, Classified
  Artis Q.zen floor, Model Number 10848353
• Z-0967-2022 · Feb 23, 2022 · Open, Classified
  Artis zee floor, Model Number 10094135
• Z-0973-2022 · Feb 23, 2022 · Open, Classified
  Artis zeego, Model Number 10280959
• Z-0970-2022 · Feb 23, 2022 · Open, Classified
  Artis zee biplane, Model Number 10094141
• Z-0977-2022 · Feb 23, 2022 · Open, Classified
  Artis Q zeego, Model Number 10848283
• Z-0969-2022 · Feb 23, 2022 · Open, Classified
  Artis zee multi-purpose, Model Number 10094139
• Z-0976-2022 · Feb 23, 2022 · Open, Classified
  Artis Q biplane, Model Number 10848282
• Z-0975-2022 · Feb 23, 2022 · Open, Classified
  Artis Q ceiling, Model Number 10848281
• Z-0979-2022 · Feb 23, 2022 · Open, Classified
  Artis Q.zen ceiling, Model Number 10848354
• Z-0968-2022 · Feb 23, 2022 · Open, Classified
  Artis zee ceiling, Model Number 10094137
• Z-0297-2022 · Oct 20, 2021 · Terminated
  Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10094137

…and 71 more.