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FDA Device recall Z-1788-2012

GE Healthcare Revolution XR/d

On 2012-06-20 the FDA classified a Class II recall of GE Healthcare Revolution XR/d by General Electric Med Systems, citing 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 p….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1788-2012
ClassificationClass II
Statusterminated
Initiated2006-05-31
Published2012-06-20
Last updated2026-09-13 11:53 UTC
CompanyGeneral Electric Med Systems
Distributionn/a

Product

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

Identifiers

code_infoall serial numbers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1788-2012%22

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