Reported Feb 20, 2019 · Terminated
Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
Philips Medical Systems GmbH, DMC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems Gmbh, DMC · Development And Manufacturing Ctr. · Hamburg, N/A · N/A
Is this the product you have?
- Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
- Lot codes and dates
- All CombiDiagnost systems with software version 1.0.0, 1.0.1 and 1.0.2
- Amount recalled
- 146
Where it was sold
Why it was recalled
kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.
This product could cause temporary or reversible health problems — stop using it.
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