Artis zee biplane MN 10094143Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04056869010106), received between Jul 10, 2020 and Sep 1, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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

12 other recalls cover devices cleared under the same FDA submission (K122644, K141574); 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. 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-0972-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2021Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE BIPLANE MN SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT FLUORO CONTINUED AFTER THE FOOTSWITCH WAS RELEASED. 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 12406223 ↗
• MalfunctionSep 14, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE BIPLANE MN SYSTEM. THE USER REPORTED THAT THE CEILING ARM HAD FALLEN OUT OF THE SUPPORT RAILS. THE EVENT DID NOT OCCUR DURING A PATIENT PROCEDURE, AND 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 10527285 ↗
• MalfunctionJul 10, 2020Output Problem; Output Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE BIPLANE MN SYSTEM DURING AN INTERVENTIONAL PROCEDURE. THE PROCEDURE WAS CONTINUED AND FINISHED USING AN ALTERNATE SYSTEM. AT THE TIME OF THIS REPORT, ADVERSE IMPACT TO THE PATIENT'S HEALTH AS A RESULT OF THIS EVENT HAS NOT BEEN REPORTED TO SIEMENS. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO INVESTIGATE THE REPORTED EVENT. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10260222 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122644, K141574. One submission often covers many models, so check the product and lot details in each record.

• Z-2526-2018 · May 25, 2018 · Terminated
  Artis zee systems with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional proc
• Z-2313-2018 · May 1, 2018 · Terminated
  Artis zee MP, Material no. 10094139, for angiography and whole body radiographic/fluoroscopic procedures.
• Z-2312-2018 · May 1, 2018 · Terminated
  Artis zee floor MN, Material no. 10094142, for angiography and whole body radiographic/fluoroscopic procedures.
• Z-2314-2018 · May 1, 2018 · Terminated
  Artis zeego, Material no. 10280959 , for angiography and whole body radiographic/fluoroscopic procedures.
• Z-2311-2018 · May 1, 2018 · Terminated
  Artis zee floor, Material no. 10094135, for angiography and whole body radiographic/fluoroscopic procedures.
• Z-2309-2018 · May 1, 2018 · Terminated
  Artis zee biplane MN, Material no. 10094143, for angiography and whole body radiographic/fluoroscopic procedures.
• Z-2310-2018 · May 1, 2018 · Terminated
  Artis zee ceiling, Material no. 10094137, for angiography and whole body radiographic/fluoroscopic procedures.
• Z-2308-2018 · May 1, 2018 · Terminated
  Artis zee biplane, Material no. 10094141, for angiography and whole body radiographic/fluoroscopic procedures.
• Z-0710-2018 · Sep 28, 2017 · Terminated
  Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
• Z-0971-2017 · Dec 8, 2016 · Terminated
  Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging an
• Z-0602-2017 · Nov 1, 2016 · Terminated
  Artis zee/zeego, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and i
• Z-1846-2015 · May 22, 2015 · Terminated
  Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional