Class 2 Device Recall Philips Easy Diagnost ClassicStationary xray system

• Date Initiated by Firm: July 11, 2012
• Date Posted: August 15, 2012
• Recall Status: Terminated on January 23, 2017
• Recall Number: Z-2208-2012
• Recall Event ID: 62568
• 510(K)Number: K970640 K031535
• 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 MA 01810
• For Additional Information Contact: 978-687-1501
• 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: 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 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.