Medical device recalls Moderate risk

Philips Electronics North America Corporation recalls Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency…

Recall date
July 22, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0766-2016
FDA classification
Class II
Brand / firm
Philips Electronics North America Corporation
Sold / distributed
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.

Why it was recalled

If arm is not fastened securely it could fall down.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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