Biograph mCT Flow Edge-4R, System Material Number 10528955. The Siemens Biograph mCT systems are combined X-Ray Computed
FDA device recall Z-0807-2015 · posted 2014-12-16 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA Inc.
- Reason for recall
- Possibility for system display freeze during CT interventional procedures.
- Action taken
- The firm initiated their recall by certified mail on 11/13/2014.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 4 units
- Distribution
- Distributed in the states of NC and MA and the countries of Australia, Canada, Switzerland, and Germany.
- Date initiated
- 2014-11-13
- Date posted
- 2014-12-16
- Date terminated
- 2015-07-09
- 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 |