OmniDiagnost System
FDA device recall Z-0874-03 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems Sales & Service Region No. America
- Reason for recall
- Labeling of push button caps located on the control panel may not clearly identify the applied Source to Image distance (SID).
- Action taken
- On 7/17/03 the firm issued a letter dated June 12, 2003 to their customers advising that service personnel will visit the consignees and replace the buttons.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 52
- Distribution
- The firm distributed devices to 81 hospitals and medical centers located throughout the U.S.
- Date initiated
- 2003-07-17
- Date posted
- 2004-07-20
- Date terminated
- 2005-01-12
- 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 OMNIDIAGNOST (K982993) | Philips Medical Systems, Inc. | 1998-09-29 |