Practix 160 Mobile X-ray systems. The systems are used in general purpose diagnostic imaging, and are specifically used
FDA device recall Z-0763-2007 · posted 2007-09-25 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- X-ray systems lack product report certification demonstrating compliance, and were illegally introduced into the United States commerce.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 2 units
- Distribution
- Nationwide: Distributed to Puerto Rico.
- Date initiated
- 2007-03-23
- Date posted
- 2007-09-25
- Date terminated
- 2010-09-16
- Location
- Bothell, WA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRACTIX CONVENIO (K042368) | Philips Medical Systems North America Co. | 2004-10-04 |