Practix 160 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.
FDA Recall Z-0763-2007 · Posted 2007-09-25
Recalling FirmPhilips Medical Systems North America Co. Phillips
Recall StatusTerminated
Product CodeIZL
Date Initiated2007-03-23
Date Terminated2010-09-16
Product Quantity2 units
Reason for Recall
X-ray systems lack product report certification demonstrating compliance, and were illegally introduced into the United States commerce.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide: Distributed to Puerto Rico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.