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Recall Observatory FDA recall evidence

Device product

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.

Z-1790-2012

May 31, 2006

Class II

Product summary

Firm
General Electric Med Systems LLC
Event
Event 37654
Status
Terminated
Classification
Class II
Quantity
3,796 units
Official record key
device-enforcement:Z-1790-2012

Official wording

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

Code information: All serial numbers

Distribution pattern: Worldwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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