Recall Z-1538-2012— Philips Healthcare Inc.
Class II · Terminated
Class II FDA medical device recall by Philips Healthcare Inc., initiated 2011-10-19, terminated 2017-01-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide. Reason: 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.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-10-19
- Terminated
- 2017-01-18
- Firm location
- Andover, MA, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.