FDA DevicesClass II
ARTIS icono ceiling. Model Number: 11328100.
Published: July 8, 2026Recall ID: Z-2648-2026Category: devicesCountry: US
Reason for Recall / Hazard
Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.
Product Description & Identification
ARTIS icono ceiling. Model Number: 11328100.
Additional Source Details
| Field | Value |
|---|---|
| City | Malvern |
| State | PA |
| Event id | 99224 |
| Address 1 | 40 Liberty Blvd |
| Address 2 | N/A |
| Code info | Model Number: 11328100. UDI-DI: 4056869295923. |
| Postal code | 19355-1418 |
| Report date | 20260708 |
| Product type | Devices |
| Product quantity | 57 units |
| Reason for recall | Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260608 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260701 |
Overview
- Recalling FirmSiemens Medical Solutions USA, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of CA, GA, IA, IN, LA, MO, NC, NY, PA, SC.