Gyroscan ACS-NT system
FDA device recall Z-1199-03 · posted 2003-09-12 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- Patient burns related to high SAR levels and the combined use of Synergy Body Coil and synergy Flex-M coil
- Action taken
- The firm issued a Field Change Order to their field personnel instructing them to add new labeling to the User Manual. 05/02/2002 A letter was issued to customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 112 total for all 3 devices
- Distribution
- The firm distributed units to hospitals and medical centers nationwide.
- Date initiated
- 2002-05-02
- Date posted
- 2003-09-12
- Date terminated
- 2005-04-11
- Location
- Bothell, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS GYROSCAN TN 15 (K932645) | Philips Medical Systems, Inc. | 1993-12-13 |