FDA Enforcement
Class II
Terminated
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.
Recall: Z-1788-2012
·
Reported June 20, 2012
Enforcement
- Recall Number
- Z-1788-2012
- Event ID
- 37654
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- General Electric Med Systems LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 20, 2012
- Initiation Date
- May 31, 2006
- Classification Date
- June 8, 2012
- Termination Date
- July 31, 2012
- Address
- 3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States
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
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
Code Info
all serial numbers
Distribution
Worldwide Distribution.
Quantity
3,796 units