CLASS II Device recall · Reported 17 Feb 2016 · FDA Enforcement Report

Philips Healthcare TraumaDiagnost recalled by Philips Electronics North

Philips Electronics North America is recalling Philips Healthcare TraumaDiagnost, distributed in 10 states. The recall was initiated on 22 Jul 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll TraumaDiagnost products that were delivered before the week of July 2, 2007.

Quantity recalled399 distributed, 262 are subject to this event

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0766-2016
FDA event ID: 71764
Recalling firm: Philips Electronics North America, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 22 Jul 2015
FDA classified: 5 Feb 2016
Reported: 17 Feb 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

22 Jul 2015	Recall initiated by company
5 Feb 2016	Classified by FDA	+198 days
17 Feb 2016	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

If arm is not fastened securely it could fall down.

Product as listed by the FDA

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

Where it was 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.

Alabama California Florida Georgia Kansas Massachusetts New York Rhode Island Texas Wisconsin

Questions about this recall

Why was it recalled?

If arm is not fastened securely it could fall down.

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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