The Recall Desk
HighFDA (Devices)·Z-1788-2012·Announced 2012-06-20

GE Healthcare Revolution XR/d Recalled for Finger Pinch Hazard

General Electric is recalling 3,796 Revolution XR/d digital radiographic imaging systems worldwide due to a reported incident where an operator's finger was pinched.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where a specific injury (finger pinch) has been reported, but the source does not indicate hospitalization or severe injury, fitting the High severity criteria.

Plain-English summary

General Electric Med Systems LLC is recalling 3,796 units of the GE Healthcare Revolution XR/d Digital Radiographic Imaging System. The affected model numbers are 2259988-2 and 2351505. The device is indicated for use in generating radiographic images of human anatomy and is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures.

The recall was initiated after an incident was reported in which an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table. The injury occurred while the operator was moving the tabletop with their thumb placed over its edge and fingers underneath. The source text does not specify the severity of the injury or whether other incidents have occurred.

The affected units were distributed worldwide. The source text does not provide specific instructions for consumers or healthcare facilities on how to proceed with the recall, such as contacting the manufacturer or stopping use of the device.

The recalled product

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 repl
Manufacturer
General Electric Med Systems LLC
Category
Medical Device — Radiographic Imaging
Hazard
Affected units
3,796

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • all serial numbers

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 recalled by General Electric Med Systems LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · General Electric Med Systems LLC

See all →

Same hazard · pinch injury

See all →