Recall Z-0896-05 ยท LLZ System, Image Processing, Radiological
Philips Medical Systems North America Co. Phillips
View Forum 2003 software, SW 3.4L1
| Date | Jun 16, 2005 (initiated Apr 29, 2005) |
| Status | Terminated |
| Reason | Automated analysis of vascular obstruction tool in software gives unreliable calibration and analysis results when using unprocessed images acquired on the Philips Allura FD10. |
| Root cause | Other |
| Action | 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. |
| Quantity | 18 units |
| Distribution | The units were distributed to 18 medical centers thorughout the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032096 | PHILIPS VIEWFORUM 2003 Philips Medical Systems, Jul 18, 2003 |