Siemens Artis zee Ceiling Systems. Angiographic x-ray system.
FDA device recall Z-1080-2014 · posted 2014-02-24 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- During the lifetime of Artis zee Ceiling systems, there is an increased wear due to potential sub-optimal cable guidance that can lead to cable damage.
- Action taken
- In December 2013, a recall notification letter was sent to Users.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 284
- Distribution
- Nationwide Distribution.
- Date initiated
- 2013-12-16
- Date posted
- 2014-02-24
- Date terminated
- 2015-03-09
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTIS ZEE AND ZEEGO (K073290) | Siemens Medical Solutions USA, Inc. | 2008-02-11 |