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Terminated

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

FDA Recall Z-1538-2012 · Posted 2012-06-13

Recalling FirmPhilips Healthcare Inc.
Recall StatusTerminated
Product CodeIZL
Date Initiated2011-10-19
Date Terminated2017-01-18
Product Quantity11 - US

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

Firm 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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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