High FDA (Devices)·Z-0766-2016·Announced 2016-02-17

Philips TraumaDiagnost X-ray Units Recalled for Arm Fall Hazard

Philips is recalling TraumaDiagnost radiological examination units because the arm may not be fastened securely and could fall down.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (falling arm) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Philips Electronics North America Corporation is recalling the Philips Healthcare TraumaDiagnost radiological examination unit. The recall affects units with codes 72001, 720011, 720013, and 720020 that were delivered before the week of July 2, 2007. These units are used for emergency work and routine skeletal diagnosis.

The recall was initiated because if the arm is not fastened securely, it could fall down. A total of 399 units were distributed, and 262 are subject to this event. The affected units were distributed in the United States (NY, WI, MA, AL, FL, GA, RI, CA, KS, and TX) and in Canada, Australia, Austria, Belgium, France, Germany, Ireland, Italy, Netherlands, New Zealand, Portugal, South Africa, Spain, and Switzerland.

Healthcare facilities should contact Philips Electronics North America Corporation for instructions on how to address the issue. The U.S. Food and Drug Administration has classified this as a Class II recall.

The recalled product

Product: Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis.
Manufacturer: Philips Electronics North America Corporation
Category: Medical Device — Radiological Equipment
Hazard: falling-object

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed in 10 states:

Same manufacturer · Philips Electronics North America Corporation

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