View Forum 2003 software, SW 3.4L1
FDA device recall Z-0896-05 · posted 2005-06-16 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- Automated analysis of vascular obstruction tool in software gives unreliable calibration and analysis results when using unprocessed images acquired on the Philips Allura FD10.
- Action taken
- On 4/29/05 the firm mailed a letter, via certified return receipt. to their customers. The letter notified users of the problem and offered a work around. Consignees were advised they would be contacted by a representative to upgrade the unit with new software.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 18 units
- Distribution
- The units were distributed to 18 medical centers thorughout the US.
- Date initiated
- 2005-04-29
- Date posted
- 2005-06-16
- Date terminated
- 2008-05-09
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS VIEWFORUM 2003 (K032096) | Philips Medical Systems | 2003-07-18 |