Z-2137-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 13, 2014
- Initiation Date
- May 30, 2014
- Termination Date
- December 17, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Domestic: 100 units; Foreign: 46 units
Product Description
KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installed diagnostic x-ray system composed of 3 main components: an operator console, U-Arm assembly with x-ray tube including a collimator, and a stationary generator.
Reason for Recall
A control system failure may cause the U-Arm to move downward unexpectedly when the Radiology Technologist is positioning the equipment using the "Up" or "Down" control buttons. Downward movement occurs at three times the normal rate of speed and will continue until the device control button is released, the Emergency Stop button is activated or the equipment Bump Sensor contacts an object.
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the countries of Canada, China, Italy, Germany, Greece, Kuwait, Spain, South Africa, and United Arab Emirates.
Code Information
Service Code 1534