Recall Z-1084-05 ยท KPR System, X-Ray, Stationary
Philips Ultrasound, Inc.
Optimus 30
| Date | Nov 8, 2005 (initiated Feb 24, 2005) |
| Status | Terminated |
| Reason | Systems do not comply with the labeling performance standards. |
| Root cause | Other |
| Action | On/about 2/24/04 the firm''s representatives began visiting sites to apply appropriate labeling. The firrm''s representatives will test units to verify compliance. |
| Quantity | 44 units |
| Distribution | Devices were distributed to 38 medical centers and hospitals throughout the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945278 | PHILIPS BUCKY DIAGNOST FAMILY Philips Medical Systems North America, Inc., Dec 14, 1994 |