Recall Z-2641-2026
Siemens Medical Solutions USA, Inc · initiated May 20, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ARTIS icono biplane. Model Number: 11327600.
Codes / lots: Model Number: 11327600. UDI-DI: 4056869063317. Serial Numbers: 184246, 184241, 184086, 184178, 184108, 184099, 184070, 184127, 184095, 184167, 184184, 184205, 184199, 184221, 184126, 184047, 184093, 184044, 184096, 184214, 184100, 184119, 184073, 184188, 184134, 184150, 184081, 184153, 184085, 184243, 184117, 184045, 184159, 184151, 184177, 184079, 184087, 184169, 184116, 184157, 184163, 184123, 184090, 184118, 184140, 184230, 184224, 184195, 184248, 184225, 184190, 184106, 184046, 184078, 184200, 184142, 184138, 184166, 184152, 184113, 184186, 184196, 184105, 184102, 184147, 184120, 184121, 184124, 184211, 184233, 184216, 184050, 184067, 184112, 184122, 184220, 184089, 184097, 184234, 184103, 184098, 184084, 184183, 184179, 184109
Reason for recall
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
FDA-determined cause: Software design
Action taken
Siemens notified consignees on about 05/19/2026 via letter. Consignees were instructed to ensure all users of the affected products within each organization and others who may need to be informed will receive the relevant safety information provided within the notice and comply with the recommendations therein, maintain the recall notification with product related records and until the corrective measures have been completed. Siemens will be releasing a software update to correct the issue via an Update Instruction AX018/26/S. All affected systems will be corrected by Siemens Healthineers. The service organization will contact consignees in the near future to arrange a date to perform the corrective action. Additionally, consignees were instructed to confirm and acknowledge receipt of the recall notification digitally.
Details
- Recall number
- Z-2641-2026
- Initiated
- May 20, 2026
- Posted by FDA
- July 1, 2026
- Product code
- OWB – Interventional Fluoroscopic X-Ray System
- Quantity
- 85 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- Siemens Medical Solutions USA, Inc, Malvern, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2642-2026 Class II | ARTIS icono ceiling. Model Number: 11328100.Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum… | 05/20/2026Open, Classified |
| Z-2643-2026 Class II | ARTIS icono floor. Model Number: 11327700.Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum… | 05/20/2026Open, Classified |