Recall Z-0469-2021 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material numbers 10848281, 10848354, 10094135, 10848354 - 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 | Oct 21, 2020 |
| Status | Terminated |
| Reason | Some electronic components within the generator were equipped with an incorrect protection diode. As a result, protection against overvoltage may be inadequate, and the system may not function properly in the event an overvoltage situation occurs. |
| Root cause | Employee error |
| Action | On October 21, 2020, the firm notified customers via Urgent Medical Device Correction letter. The letter informed customers of the hardware error, and that customers could continue to use their system but needed to follow their standard emergency procedures they had in place in the event of system failures. It is recommended to consider reinforcing these emergency procedures until the update has been completed. Siemens advises that an alternative system is available to continue treatment in case of occurrence. Siemens is implementing a corrective action to all affected users via Update Instru |
| Quantity | 26 distributed worldwide (4 in US) |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of AR, CA, IA, IL and the countries of China, Germany, India, Indonesia, Italy, Japan, Philippines, Saudi Arabia, South Korea, Taiwan, Turkey, and United Kingdom. |
| 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 |