Easy Access PACS System with software Release 5, 6.2, or 7.2
FDA device recall Z-1223-03 · posted 2003-09-12 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- Potential display of an incorrect body part description on patient images.
- Action taken
- On 2/13/02 the firm issued a letter to their consignees. The letter provided a remedy to the situtaion.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 46 units
- Distribution
- The firm distributed units to 46 hospitals and medical centers located throughout the U.S.
- Date initiated
- 2002-02-13
- 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 |
|---|---|---|
| WISE (II) IMAGE MANAGEMENT SYSTEM (K983447) | Sectra-Imtec AB | 1998-10-29 |