Z-1788-2012 Class II Terminated
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 Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model numbers: 2259988-2 & 2351505. The Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in all general-purpose diagnostic procedures. This device is not intended for mammographic applications.
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