FDAFDA · Food and drugs·Recall number Z-1788-2012
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.
Published June 20, 2012 · Recall initiated: May 31, 2006
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- General Electric Med Systems LLC
- Distributor
- Worldwide Distribution.
- Lot
- all serial numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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