Recall Z-1496-2020 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
| Date | Mar 13, 2020 (initiated Feb 14, 2020) |
| Status | Terminated |
| Reason | A software issue could potentially cause the stand and table movements to be blocked. |
| Root cause | Software design |
| Action | On February 14, 2020, the firm distributed Urgent Medical Device Correction letters to customers. Customers were informed of the software error which affects the listed systems. In case of software failure, planned procedures may have to be terminated and performed on an alternative x-ray system. Customers were instructed to do the following: Issue # 1: Potential issue with the Message "Stand battery charging: DO NOT POWER OFF" on Artis zeego systems Customer Action: Please check the system messages before power off/shutdown of the system. If possible, do not switch off the system while the |
| Quantity | 1452 worldwide (638 US) |
| Distribution | US Nationwide distribuiton. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181407 | Artis zee/zeego & Artis Q/Q.zen Siemens Medical Solution USA, Inc., Aug 15, 2018 |