Device product
Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
Z-0612-2019
Product summary
- Event
- Event 81706
- Status
- Terminated
- Classification
- Class II
- Quantity
- 146
- Official record key
device-enforcement:Z-0612-2019
Official wording
Reason: kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.
Code information: All CombiDiagnost systems with software version 1.0.0, 1.0.1 and 1.0.2
Distribution pattern: 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.
Derived failure modes
-
Unknown
kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.