Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
Reported: February 20, 2019 Initiated: November 7, 2018 #Z-0612-2019
Product Description
Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
Reason for Recall
kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.
Details
- Recalling Firm
- Philips Medical Systems Gmbh, DMC
- Units Affected
- 146
- Distribution
- 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.
- Location
- Hamburg, N/A
Frequently Asked Questions
What product was recalled? ▼
Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System. Recalled by Philips Medical Systems Gmbh, DMC. Units affected: 146.
Why was this product recalled? ▼
kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 20, 2019. Severity: Moderate. Recall number: Z-0612-2019.
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