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FDA device recall Z-0695-05 · posted 2005-04-08 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems Sales & Service Region No. America
- Reason for recall
- Failure to update correctly when re-transmitting an image from the modality.
- Action taken
- The firm mailed a letter on January 31, 2005, certified return receipt to their customers advising that a service representative will visit each site and install new software.
- Root cause
- Other
- Status
- Terminated
- Product code
- LMB
- Quantity affected
- 60
- Distribution
- Devices distributed to hospitals and medical centers located throughout the U.S.
- Date initiated
- 2005-02-16
- Date posted
- 2005-04-08
- Date terminated
- 2006-02-13
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WISE (II) IMAGE MANAGEMENT SYSTEM (K983447) | Sectra-Imtec AB | 1998-10-29 |