—#111064

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.

FDA product code: IXR — Table, Radiographic, Tilting
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K031535, K970640
Affected lot / code info: Serial Numbers: SN07000141 SN07000109 SN5000162 SN5000421 SN07000667 200148 200115 200081 300114

Why it was recalled

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.

Root cause (FDA determination)

Equipment maintenance

Action the firm took

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

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: Worldwide Distribution - USA including IN, MA, MI, MO, NC, NY PA, SC, and WI and to the countries of Canada, HongKong, New Zealand.

Timeline

Recall initiated: 2012-07-11
Posted by FDA: 2012-08-15
Terminated: 2017-01-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #111064. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.