Philips Medical Systems, Inc. recalls Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column,

Recalled December 24, 2014 · FDA recall Z-0508-2015 · Philips Medical Systems

Hazard

In special cases, during the start-up of the current model of MobileDiagnost wDR(WmDR 1.1), an unintended exposure could occur. · FDA Class II

Units

247 in US, 1 in Puerto Rico

Sold at

Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA and WI.,and the countries of : Argentina, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Iraq, Ireland, Italy, Jordan, Liberia, Mexico, Netherlands, New Zealand, Norway, Oman, Panama, Portugal, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, United Arab Emirates and United Kingdom.

Description

In special cases, during the start-up of the current model of MobileDiagnost wDR(WmDR 1.1), an unintended exposure could occur.

Product

Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with the patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.

Manufacturer(s)

Philips Medical Systems, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →