FDA Medical Device · Z-1790-2012

GE Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee, WI. Model Number: 2259988. Product is indicated for use in generating radiographic images of human anatomy in all general-purpose diagnostic procedures. This device is not intended for mammographic applications.

Class II · Terminated

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

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Affected lots / codes — check yours against thisAll serial numbers
Recalling firm
General Electric Med Systems LLC, Waukesha, WI
Classification
Class II (temporary or reversible harm possible)
Status
Terminated
Quantity
3,796 units
Distribution
Worldwide Distribution.
Recall initiated
May 31, 2006
Classified
June 8, 2012
Terminated
July 31, 2012
Initiation
Voluntary: Firm initiated
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Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1790-2012%22
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Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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