FDA DevicesClass II
ARTIS icono biplane. Model Number: 11327600.
Published: July 8, 2026Recall ID: Z-2641-2026Category: devicesCountry: US
Reason for Recall / Hazard
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Product Description & Identification
ARTIS icono biplane. Model Number: 11327600.
Additional Source Details
| Field | Value |
|---|---|
| City | Malvern |
| State | PA |
| Event id | 99079 |
| Address 1 | 40 Liberty Blvd |
| Address 2 | N/A |
| Code info | 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 |
| Postal code | 19355-1418 |
| Report date | 20260708 |
| Product type | Devices |
| Product quantity | 85 units |
| Reason for recall | Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260520 |
| Initial firm notification | Letter |
| Center classification date | 20260701 |
Overview
- Recalling FirmSiemens Medical Solutions USA, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution.