System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane
FDA device recall Z-1040-2023 · posted 2023-01-30 · Open, Classified
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach full operating mode. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system.
- Action taken
- On December 16, 2022, the firm initiated the recall to its affected customers via Urgent Medical Device Correction letters. Customers were instructed to do the following: Observe if the system suffers an abrupt shutdown. This can be caused e.g., by usage of the Emergency SHUTDOWN button, manually switching off via End session / Shutdown System command in the main menu, or by a long press on the power-on push button on the system console. In the event of an abrupt shutdown, restart immediately to verify system state and call service if necessary. The firm will provide a software patch to affected systems. Siemens's service organization will contact customers to arrange a date to perform the corrective action. Please feel free to contact the service organization for an earlier appointment at 1-800-888-7436.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 609 US; 1627 worldwide
- Distribution
- Worldwide - US Nationwide distribution.
- Date initiated
- 2022-12-16
- Date posted
- 2023-01-30
- 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 zee/zeego & Artis Q/Q.zen (K181407) | Siemens Medical Solution USA, Inc. | 2018-08-15 |