FDA DevicesClass II
ARTIS icono floor. Model Number: 11327700.
Published: July 8, 2026Recall ID: Z-2643-2026Category: 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 floor. Model Number: 11327700.
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: 11327700. UDI-DI: 4056869149325. Serial Numbers: 174132, 174128, 174085, 174152, 174056, 174055, 174083, 174121, 174122, 174087, 174044, 174061, 174099, 174058, 174063, 174150, 174126, 174125, 174096, 174145, 174101, 174065, 174076, 174078, 174091, 174149, 174059, 174073, 174081, 174067. |
| Postal code | 19355-1418 |
| Report date | 20260708 |
| Product type | Devices |
| Product quantity | 30 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.