Biograph mCT S(64)-4R, Model Number 10248672
FDA device recall Z-2332-2015 · posted 2015-08-05 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA Inc.
- Reason for recall
- Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.
- Action taken
- The firm initiated their recall on 07/14/2015 by telephone to the sole US consignee. The update is scheduled for 07/15/2015.
- Root cause
- Packaging change control
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 1 unit
- Distribution
- Distributed in the state of Texas and the countries of Germany, France, Russia, Denmark, and Switzerland.
- Date initiated
- 2015-07-14
- Date posted
- 2015-08-05
- Date terminated
- 2016-03-03
- Location
- Knoxville, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOGRAPH MCT FAMILY (K123737) | Siemens Medical Solutions USA, Inc. | 2013-01-29 |