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Philips Medical Systems Gmbh, DMC recalls Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
Recalled February 20, 2019 · FDA recall Z-0612-2019 · Philips Medical Systems Gmbh, DMC
Hazard
kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose. · FDA Class II
Units
146
Sold at
Worldwide Distribution: US (nationwide) to states of: AZ, CA, GA, IL, MN, MO, MT, NJ, OH, TX, UT & VA; and to countries of: Australia, Austria, Bangladesh, Belgium, Chile C¿te D'Ivoire, Czech Republic. Egypt, Ethiopia, France, Germany, Ghana, Iran, Italy, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Martinique, Mexico, Nepal, Netherlands, New Zealand, Philippines, Portugal Russian Federation, Rwanda, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates and United Kingdom.
Description
kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.
Product
Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
Manufacturer(s)
Philips Medical Systems Gmbh, DMC
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →