Artis zee floor MN 10094142Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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-0971-2022 · Root cause: Device Design · Recall details · FDA record ↗

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-2312-2018 · May 1, 2018 · Terminated
  Artis zee floor MN, Material no. 10094142, 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-2314-2018 · May 1, 2018 · Terminated
  Artis zeego, Material no. 10280959 , 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-2313-2018 · May 1, 2018 · Terminated
  Artis zee MP, Material no. 10094139, 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-2311-2018 · May 1, 2018 · Terminated
  Artis zee floor, Material no. 10094135, 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