Recall Z-0119-2023 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Siemens Medical Solutions USA, Inc
ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000
| Date | Oct 21, 2022 (initiated Sep 20, 2022) |
| Status | Open, Classified |
| Reason | Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system. |
| Root cause | Software design |
| Action | On September 20, 2022, the firm notified affected customers via Urgent Medical Device Correction letters. This notification covered three issues. 1. System Error Management, in which the operator is unable to release X-Ray in "Bypass fluoroscopy" mode which remains permanently inhibited, and may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system. Customers should ensure that patient treatment can be continued in other ways if there is any possible danger for the safety of the patient. 2. Head Holder Symbols, in which the |
| Quantity | 140 US |
| Distribution | Domestic distribution nationwide. Foreign distribution worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163286 | ARTIS pheno Siemens Medical Solution USA, Inc., Mar 9, 2017 |