Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide
This recall has been terminated (originally issued June 13, 2012).
- Company
- Philips Healthcare Inc.
- Recall Initiated
- October 19, 2011
- Posted
- June 13, 2012
- Terminated
- January 18, 2017
- Recall Number
- Z-1538-2012
- Quantity
- 11 - US
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
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
Distribution
Nationwide Distribution
Root Cause
Radiation Control for Health and Safety Act
Action Taken
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.