General Electric Med Systems LLC: Medical Device Recall in 2012 - (Recall #: Z-1789-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 31, 2006

Date Posted: June 20, 2012

Recall Number: Z-1789-2012

Event ID: 37654

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

Status: Terminated

Product Quantity: 3,796 units

Code Information:

All serial numbers

Distribution Pattern:

Worldwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated