GE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model Number: 5131070. The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic images of human anatomy. It is not intended for mammographic use.
This recall has been terminated (originally issued June 8, 2012).
- Company
- General Electric Med Systems Llc
- Recall Initiated
- May 31, 2006
- Posted
- June 8, 2012
- Terminated
- July 31, 2012
- Recall Number
- Z-1789-2012
- Quantity
- 3,796 units
- Firm Location
- Waukesha, WI
- Official Source
- View on FDA website ↗
Reason for Recall
An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath
Distribution
Worldwide Distribution.
Lot / Code Info
All serial numbers
Root Cause
Device Design
Action Taken
GE Healthcare sent an "URGENT SAFETY INFORMATION" letter dated May 31, 2006 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included new operator instructions and warning labels.
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