Artis Zee Angiographic x-ray systems.
FDA device recall Z-1309-2014 · posted 2014-03-31 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- An inappropriate cable connection was assembled for certain Artis zee systems. which may cause a system failure and possibly lead to a restricted maneuverability of the gantry system.
- Action taken
- A recall notification letter dated February 7, 2014, was sent to End Users.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 9
- Distribution
- MN, WI, PA, MI, AL, OH, NC, AR, and NJ.
- Date initiated
- 2014-02-07
- Date posted
- 2014-03-31
- Date terminated
- 2015-03-16
- 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 AND ZEEGO (K073290) | Siemens Medical Solutions USA, Inc. | 2008-02-11 |