Gyroscan NT-Intera
FDA device recall Z-1228-03 · posted 2003-09-12 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- Patient burns from cables near or in contact with the patient during use
- Action taken
- On 11/21/02, the firm provided Field Change Order (FCO) 781 00006 to their field employees. This FCO instructed the field employees to visit the consignees and provide them with the addendums to the Instruction For Use Manual.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Distribution
- The firm distributed units to hospitals and medical centers throughout the U.S.
- Date initiated
- 2002-11-21
- Date posted
- 2003-09-12
- Date terminated
- 2005-01-13
- 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 |