Recall Z-2137-2014— Carestream Health Inc.
Class II · Terminated
Class II FDA medical device recall by Carestream Health Inc., initiated 2014-05-30, terminated 2014-12-17. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Carestream Health Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-05-30
- Terminated
- 2014-12-17
- Firm location
- Rochester, NY, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.