The Recall Desk
HighFDA (Devices)·Z-1790-2012·Announced 2012-06-20

GE Proteus XR/a Radiographic System Recalled Due to Pinch Hazard

General Electric is recalling 3,796 Proteus XR/a Radiographic Systems worldwide because an operator's finger was pinched between the fixed roller and the gliding tabletop.

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 (pinched finger) has been reported, but the source does not indicate fatalities, serious injuries, or FDA Class I classification.

Plain-English summary

General Electric Medical Systems LLC is recalling 3,796 units of the GE Proteus XR/a Radiographic System (Model Number: 2259988) due to a reported safety incident. The product is indicated for use in generating radiographic images of human anatomy in all general-purpose diagnostic procedures and is not intended for mammographic applications. The recall covers all serial numbers and the product was distributed worldwide.

The recall was initiated after an incident was reported where an operator's finger was pinched between the fixed roller and the gliding tabletop of the device. The injury occurred while the operator was moving the tabletop with their thumb placed over its edge and fingers underneath.

Healthcare facilities and users of the GE Proteus XR/a Radiographic System should stop using the device and contact General Electric Medical Systems LLC for further instructions on the recall and potential corrective actions.

The recalled product

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 a
Manufacturer
General Electric Med Systems LLC
Category
Medical Device — Radiographic System
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

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Same hazard · pinch injury

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