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Recall Observatory FDA recall evidence

Device product

Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis.

Z-0766-2016

July 22, 2015

Class II

Product summary

Firm
Philips Electronics North America Corporation
Event
Event 71764
Status
Terminated
Classification
Class II
Quantity
399 distributed, 262 are subject to this event
Official record key
device-enforcement:Z-0766-2016

Official wording

Reason: If arm is not fastened securely it could fall down.

Code information: All TraumaDiagnost products that were delivered before the week of July 2, 2007.

Distribution pattern: Distributed in the states of NY, WI, MA, AL, FL, GA, RI, CA, KS, and TX, and the countries of Canada, Australia, Austria, Belgium, France, Germany, Ireland, Italy, Netherlands, New Zealand, Portugal, South Africa, Spain, and Switzerland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    If arm is not fastened securely it could fall down.