Z-0764-2007

Practix 300 Mobile X-ray systems. The systems are used in general purpose diagnostic imaging, and are...

Name: Z-0764-2007 Practix 300 Mobile X-ray systems. The systems are used in general purpose diagnostic imaging, and are...
Creator: Philips Medical Systems North America Co. Phillips
Published: 2007-03-23
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2007-03-23 / Terminated

FDA source

Philips Medical Systems North America Co. Phillips began a recall of Practix 300 Mobile X-ray systems. The systems are used in general purpose diagnostic imaging, and are specifically used as mobile X-ray systems for bedside... on 2007-03-23. The reason FDA records is "X-ray systems lack product report certification demonstrating compliance, and were illegally introduced into the United States commerce". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0764-2007
Status: Terminated
Initiated: 2007-03-23
Posted: 2007-09-25
Terminated: 2010-09-16
Recalling firm: Philips North America LLC
Product: Practix 300 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.
Product code: IZL System, X-Ray, Mobile
Reason for recall: X-ray systems lack product report certification demonstrating compliance, and were illegally introduced into the United States commerce.
FDA 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 in commerce: 9 units
Distribution: Nationwide: Distributed to Puerto Rico.
Product codes and lots: Serial numbers 4561206, 6561652, 6561768, 6561732, 6561728, 6561730, 6561767, 355142, and 06561731

Product code IZL

K042368Class IIPractix ConvenioPhilips Medical Systems North America Co. / cleared 2004-10-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)