Diagnost 97
FDA device recall Z-1213-03 · posted 2003-09-11 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems Sales & Service Region No. America
- Reason for recall
- Potential for table to move by itself
- Action taken
- The firm issued a letter dated 8/10/03 informing the consignees of the error and advising that a service employee will be visiting each site for software upgrade.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZZ
- Quantity affected
- see above
- Distribution
- The firm distributed devices to hospitals and medical centers located throughout the U.S.
- Date initiated
- 2003-08-10
- Date posted
- 2003-09-11
- 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 DIAGNOST 96 (K912470) | Philips Medical Systems, Inc. | 1991-08-07 |