General Electric Med Systems LLC: 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

Agency Publication Date: June 8, 2012

Affected Products

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.

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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.

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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.

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 37654

Status: Resolved

Manufacturer: General Electric Med Systems LLC

Manufactured In: United States

Units Affected: 3 products (3,796 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

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