The Recall Desk
HighFDA (Devices)·Z-0914-2017·Announced 2017-01-04

GE Healthcare Recalls Prestilix Systems Due to Potential Monitor Fall Hazard

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

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, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

GE Healthcare, LLC is conducting a recall of Prestilix and other medical imaging systems, including Prestige 2, 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.

A total of 1,598 units are affected, with 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.

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 recalled product

Product
Prestilix
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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