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FDA device recall Z-1128-03 · posted 2003-08-12 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- Potential for incorrect body part information
- Action taken
- A letter dated 2/13/02 was issued to customers advising that a representative from the firm will install new software.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 28
- Distribution
- The firm distributed units to hospitals and medical centers located throughout the US.
- Date initiated
- 2002-02-13
- Date posted
- 2003-08-12
- Date terminated
- 2005-01-12
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MITRA IMAGING INC. EXHIBIT (K982769) | Mitra Imaging, Inc. | 1998-11-03 |