FDAFDA · Food and drugs·Recall number Z-1538-2012
Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide
Published June 20, 2012 · Recall initiated: October 19, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Healthcare Inc.
- Distributor
- Nationwide Distribution
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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