Philips Medical Systems Gmbh, DMC recalls Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
- Recall date
- November 7, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0612-2019
- FDA classification
- Class II
- Brand / firm
- Philips Medical Systems Gmbh, DMC
- Sold / distributed
- 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, Malays…
Why it was recalled
kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
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