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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Easy Diagnost ClassicStationary xray system

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 Class 2 Recall
Philips Easy Diagnost ClassicStationary xray system
see related information
Date Posted August 15, 2012
Recall Status1 Open
Recall Number Z-2208-2012
Recall Event ID 62568
Premarket Notification
510(K) Numbers
K031535  K970640 
Product Classification Table, Radiographic, Tilting - Product Code IXR
Product Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use.
Code Information Serial Numbers: SN07000141 SN07000109 SN5000162 SN5000421 SN07000667 200148 200115 200081 300114
Recalling Firm/
Manufacturer
Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810
Manufacturer Reason
for Recall
Inclination switch in the stand may have been mounted incorrectly, as a result, the switch could not stop the tilting movement of the table base due tol hardware or software errors.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Equipment Maintenance
Action Philips issued an Urgent Field Safety Notice dated July 9, 2012, to notify users that the inclination swtich may be mounted incorrectly. A Field Safety Engineer will be dispatched to verify if a switch was installed properly, and in the event it was not installed properly they will re-install it properly. The Field Service Engineer will add a label as described in the spare part replacement manual, which is part of the FCO kit.. Customers were instructed review the information contained in the Field Safety Notice and to retain a copy of the notice with the equipment Instruction for Use. For further questions customers were instructed to call their Phillips representataive Technical Support Line at 1-800-722-9377. For questions regarding this recall call 978-687-1501.
Quantity in Commerce 12 units
Distribution Worldwide Distribution - USA including IN, MA, MI, MO, NC, NY PA, SC, and WI and to the countries of Canada, HongKong, New Zealand.
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.
510(K) Database 510(K)s with Product Code = IXR and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
510(K)s with Product Code = IXR and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
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