Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide
FDA Recall #Z-1538-2012 — Class II — October 19, 2011
Product Description
Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide
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
Recalling Firm
Philips Healthcare Inc. — Andover, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
11 - US
Distribution
Nationwide Distribution
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated