medical Class II Updated 2019-02-20

Philips Medical Systems Gmbh, DMC recalls Stationary Fluoroscopic X-ray System CombiDiagnost R90, Mode

Recalled Product

Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System

Hazard / Issue

kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All CombiDiagnost systems with software version 1.0.0, 1.0.1 and 1.0.2
View official government recall

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