Artis pheno- Model No. 10849000
Check against the official notice below — it lists the full affected range.
Siemens Medical Solutions USA, Inc. is recalling Artis pheno, Artis Q, Artis Q.zen, and Artis icono X-ray systems that contain X-ray tubes from a specific lot due to a potential hardware issue. In rare cases, if the error detection mechanism fails, the system will not be able to release X-rays until the system is shut down. A total of 1,389 units have been distributed worldwide, including 590 in the United States and 799 outside the United States to multiple countries.
The affected systems can be identified by UDI-DI 04056869046877 and specific serial numbers listed in the recall notice, with the serial number list updated as of January 9, 2023. The recall source does not specify a remedy or action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.
Reason for recall: Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown. Distribution: Worldwide Distribution: US (nationwide) and OUS (Foreign) to countries of: United Arab Emirates; Armenia; Angola; Argentina; Austria; Australia; Bangladesh; Belgium; Bulgaria; Bahrain; Brazil; Canada; Switzerland; China; Colombia; Costa Rica; Czech Republic; Germany; Denmark; Dominican Republic; Algeria; Estonia; Egypt; Spain; Finland; France; United Kingdom; Greece; Guatemala; Hong Kong; Croatia; Quantity: 1,389 (590 US; 799 OUS) (Total) Lot/code info: UDI-DI: 04056869046877 Serial Numbers 164766 164140 164138 164287 164740 164210 164183 164184 164776 164312 164071 164034 164391 164763 164306 164735 164277 164095 164072 164771 164743 164048 164741 164241 164186 164069 164213 164728 164263 164060 164113 164398 164366 164279 164774 164074 164084 164086 164098 164153 164330 164389 164394 164772 164718 164163 164297 164778 164333 164377 164397 164300 164105 164227 164022 164250 164739 164703 164187 164211 164100 164097 164775 164303 164352 164726 164724 164760 164371 ***Updated 9/23/22*** 164794 164400 ***Updated 1/9/23*** 164793 164172 164795
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.