ARTIS icono ceiling. Model Number: 11328100.
FDA device recall Z-2642-2026 · posted 2026-07-01 · Open, Classified
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
- Action taken
- Siemens notified consignees on about 05/19/2026 via letter. Consignees were instructed to ensure all users of the affected products within each organization and others who may need to be informed will receive the relevant safety information provided within the notice and comply with the recommendations therein, maintain the recall notification with product related records and until the corrective measures have been completed. Siemens will be releasing a software update to correct the issue via an Update Instruction AX018/26/S. All affected systems will be corrected by Siemens Healthineers. The service organization will contact consignees in the near future to arrange a date to perform the corrective action. Additionally, consignees were instructed to confirm and acknowledge receipt of the recall notification digitally.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 119 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2026-05-20
- Date posted
- 2026-07-01
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A) (K241572) | Siemens Medical Solutions USA, Inc. | 2024-10-22 |