The Recall Desk
HighFDA (Devices)·Z-0911-2017·Announced 2017-01-04

GE Healthcare Recalls Prestige II Systems Due to CRT Monitor Fall Risk

GE Healthcare is recalling Prestige II and other systems because aged CRT monitors may fall. The recall covers 1,598 units in the US and abroad.

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 monitors) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

GE Healthcare, LLC is conducting a recall of Prestige II and other medical imaging systems, including Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX, and Innova 2000. The recall is due to the potential for aged CRT monitors to fall from the systems.

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

The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself. No illnesses or injuries are reported in the provided text.

The recalled product

Product
Prestige II
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Imaging 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 →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · falling object

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