Z-1538-2012Class II

Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide

Name: Z-1538-2012 Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide
Creator: Philips Healthcare Inc.
Published: 2011-10-19
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2011-10-19 / Terminated

FDA source

Philips Healthcare Inc. began a recall of Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide on 2011-10-19. FDA classified it as Class II and gives the reason as "When the system is switched off or when the tube arm is parked in the down position (X-ray generator switch off), a radiation pulse (50 kV, 2.5 pGy) is generated inadvertently. .When the system is switched off or when...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1538-2012
Classification: Class II
Status: Terminated
Initiated: 2011-10-19
Posted: 2012-06-13
Terminated: 2017-01-18
Recalling firm: Philips North America LLC
Product: Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide
Product code: IZL System, X-Ray, Mobile
Reason for recall: When the system is switched off or when the tube arm is parked in the down position (X-ray generator switch off), a radiation pulse (50 kV, 2.5 pGy) is generated inadvertently. .When the system is switched off or when the tube arm is parked in the down position (X-ray generator switch off), a radiation pulse (50 kV, 2.5 pGy) is generated inadvertently. The failure happened when component supplie
FDA root cause: Radiation Control for Health and Safety Act
Action: Philips Healthcare sent a proprosed corrective action letter dated May 3, 2012, to FDA. The proposed corrective action plan is to bring the product into compliance with regulatory requirements by issuing a field corrective action which should be completed by Philips by August 1, 2012. For questions regarding this recall call 978-687-1501.
Quantity in commerce: 11 - US
Distribution: Nationwide Distribution
Product codes and lots: n/a

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1538-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1538-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-20	2012-06-13

Product code IZL

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)