BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Com
FDA device recall Z-1997-2016 · posted 2016-06-15 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA Inc.
- Reason for recall
- The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service.
- Action taken
- Siemens sent a Customer Safety Advisory Letter to all affected customers. The letter identified the affected product, problem and actions to be taken. Siemens service organization will be contacting customers to schedule the update as per the attached Update Instruction and will be provided the replacement bracket to resolve the issue. For questions contact your Siemens representative.
- Root cause
- Process design
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 1 unit
- Distribution
- Worldwide Distribution - US Nationwide and the countries of China and Malaysia.
- Date initiated
- 2016-04-25
- Date posted
- 2016-06-15
- Date terminated
- 2017-02-01
- 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 |