MD4 X-ray system
FDA device recall Z-0852-06 · posted 2006-05-06 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- Potential for unexpected table movement.
- Action taken
- On 4/6/06 the firm issued a letter to consignees advising of the problem. The letter advises consignees to conduct a test on their unit(s) for a possible short until the firm is able to upgrade the units.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 100 units
- Distribution
- Units were distributed to hospitals and medical centers located throughou the US.
- Date initiated
- 2006-04-06
- Date posted
- 2006-05-06
- Date terminated
- 2008-05-21
- 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 MULTIDIAGNOST 4 (K961374) | Philips Medical Systems, Inc. | 1996-08-19 |