FDA DevicesClass II
ARTIS icono ceiling. Model Number: 11328100.
Published: July 8, 2026Recall ID: Z-2642-2026Category: 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 ceiling. Model Number: 11328100.
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: 11328100. UDI-DI: 4056869295923. Serial Numbers: 194180, 194184, 194169, 194101, 194131, 194223, 194193, 194216, 194215, 194080, 194186, 194164, 194102, 194054, 194181, 194185, 194194, 194188, 194095, 194094, 194093, 194090, 194086, 194203, 194037, 194116, 194114, 194207, 194209, 194120, 194177, 194036, 194038, 194213, 194103, 194190, 194096, 194139, 194165, 194066, 194210, 194098, 194221, 194072, 194047, 194212, 194226, 194197, 194141, 194039, 194088, 194204, 194113, 194222, 194083, 194128, 194219, 194146, 194145, 194099, 194205, 194200, 194081, 194082, 194218, 194147, 194189, 194109, 194183, 194187, 194105, 194119, 194201, 194050, 194049, 194174, 194199, 194079, 194135, 194085, 194125, 194034, 194121, 194111, 194158, 194092, 194133, 194220, 194192, 194071, 194136, 194182, 194161, 194162, 194211, 194127, 194126, 194124, 194123, 194122, 194108, 194175, 194035, 194225, 194149, 194107, 194208, 194104, 194089, 194227, 194041, 194040, 194173, 194179, 194163, 194172, 194143, 1... [TRUNCATED] |
| Postal code | 19355-1418 |
| Report date | 20260708 |
| Product type | Devices |
| Product quantity | 119 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.