The Recall Desk
HighFDA (Devices)·Z-0916-2017·Announced 2017-01-04

GE Healthcare Recalls X-Ray Systems Due to CRT Monitor Fall Risk

GE Healthcare is recalling specific X-ray systems because aged CRT monitors may fall. The recall covers 1,598 units distributed in the US and internationally.

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 (falling monitor) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

GE Healthcare, LLC is conducting a recall of specific X-ray systems, including the Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX, and Innova 2000 models. The recall is being conducted due to the potential for aged CRT monitors to fall from these systems.

A total of 1,598 units are affected by this recall. The distribution includes 824 units in the United States and 774 units outside the US. The affected units were distributed across numerous US states and various international locations, including Canada, the United Kingdom, and Germany.

The source text does not specify specific actions for consumers or healthcare providers, nor does it report any injuries or illnesses associated with this defect. The recall is identified by the agency as Class II.

The recalled product

Product
SFX
Manufacturer
GE Healthcare, LLC
Category
Medical Device — X-Ray Systems
Hazard

Distribution

Distributed in 41 states:

Part of a larger recall action

This product is one of 13 recalled by GE Healthcare, 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 13 products in this recall →

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