Recall Z-1789-2012— General Electric Med Systems LLC

Name: FDA recall Z-1789-2012
Creator: U.S. Food and Drug Administration
Published: 2006-05-31

Class II · Terminated

Class II FDA medical device recall by General Electric Med Systems LLC, initiated 2006-05-31, terminated 2012-07-31. It names one FDA 510(k) clearance: K012389. Product: 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: 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.

Recalling firm: General Electric Med Systems LLC
Classification: Class II
Status: Terminated
Initiated: 2006-05-31
Terminated: 2012-07-31
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K012389 — REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEMGe Medical Systems, Inc.·cleared 2001-08-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.