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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare Practix Convenio

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 Class 2 Recall
Philips Healthcare Practix Convenio
see related information
Date Posted June 13, 2012
Recall Status1 Open
Recall Number Z-1538-2012
Recall Event ID 61830
Product Classification System, X-Ray, Mobile - Product Code IZL
Product Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide
Code Information n/a
Recalling Firm/
Manufacturer
Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810
Consumer Instructions Contact the recalling firm for information
Manufacturer 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
FDA Determined
Cause 2
RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act
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.
Quantity in Commerce 11 - US
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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