Diagnost 94
FDA device recall Z-1203-03 · posted 2003-09-12 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- Spontaneous movement of table without input from an operator
- Action taken
- On 2/20/02 the firm issued Field Change Order to their field personnel, instructing them to visit each site and upgrade each unit.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZZ
- Quantity affected
- 4
- Distribution
- The firm distributed units to hospitals and medical centers located throughout the US.
- Date initiated
- 2002-02-20
- 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 DIAGNOST 96 (K912470) | Philips Medical Systems, Inc. | 1991-08-07 |