Recall Z-0762-2007 ยท IZL System, X-Ray, Mobile
Philips Medical Systems North America Co. Phillips
Practix 33 Mobile X-ray systems. The systems are used in general purpose diagnostic imaging, and are specifically used as mobile X-ray systems for bedside radiological examinations.
| Date | Sep 25, 2007 (initiated Mar 23, 2007) |
| Status | Terminated |
| Reason | X-ray systems lack product report certification demonstrating compliance, and were illegally introduced into the United States commerce. |
| Root cause | Other |
| Action | The firm sent letters out via certified mail from 04/03/2007 through 04/09/2007 to consignees informing them of the issue. The letter indicates that the firm plans to replace consignee's systems with the Practix Convenio Mobile X-ray System at no charge by the end of May 2007. |
| Quantity | 9 units |
| Distribution | Nationwide: Distributed to Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042368 | PRACTIX CONVENIO Philips Medical Systems North America Co., Oct 4, 2004 |