ARTIS icono ceiling. Model Number: 11328100.
FDA device recall Z-2648-2026 · posted 2026-07-01 · Open, Classified
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- 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.
- Action taken
- Siemens Healthineers notified consignees on about 06/08/2026 via "CUSTOMER SAFETY ADVISORY NOTICE" letter. Consignees were instructed to conduct regular inspections of the gap between the monitor carrier and the ceiling-mounted arm and be attentive to any unusual noises, shaking, wobbling, or other unexpected behavior during system operation, as these may indicate loose screws. If any such signs are observed, limit movements of the DCS and contact Siemens service organization immediately for further instructions. Always ensure that the DCS is positioned for safe use. All affected systems will be corrected by Siemens Healthineers service engineers. Siemens engineers will correct the screwed connection of the monitor ceiling support according to the adapted specifications and instructions. The correction will be released via an Update Instruction AX022/26/S. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 57 units
- Distribution
- US Nationwide distribution in the states of CA, GA, IA, IN, LA, MO, NC, NY, PA, SC.
- Date initiated
- 2026-06-08
- Date posted
- 2026-07-01
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTIS icono (Ceiling Configuration) (K221516) | Siemens Medical Solutions USA, Inc. | 2022-07-19 |