Z-1789-2012 Class II Terminated
FDA device recall Z-1789-2012 was initiated by General Electric Med Systems LLC on May 31, 2006 and is designated Class II. 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 a… The recall status is terminated (terminated July 31, 2012). Affected quantity: 3,796 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 20, 2012
- Initiation Date
- May 31, 2006
- Termination Date
- July 31, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,796 units
Product Description
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.
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 Pattern
Worldwide Distribution.
Code Information
All serial numbers