—#109197

Product

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

FDA product code: IZL — System, X-Ray, Mobile
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: n/a

Why it was recalled

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

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2011-10-19
Posted by FDA: 2012-06-13
Terminated: 2017-01-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #109197. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.