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Recall Observatory FDA recall evidence

Device 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.

Z-2208-2012

July 11, 2012

Class II

Product summary

Firm
Philips Healthcare Inc.
Event
Event 62568
Status
Terminated
Classification
Class II
Quantity
12 units
Official record key
device-enforcement:Z-2208-2012

Official wording

Reason: 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.

Code information: Serial Numbers: SN07000141 SN07000109 SN5000162 SN5000421 SN07000667 200148 200115 200081 300114

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.