The Recall Desk
SevereFDA (Devices)·Z-0915-2017·Announced 2017-01-04

GE Healthcare Recalls RFX Systems Due to CRT Monitor Fall Risk

GE Healthcare is recalling RFX and other systems because aged CRT monitors may fall. This poses a risk of injury or property damage.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural defect (falling monitors) which poses a risk of significant injury or property damage, meeting the criteria for a Severe (4) rating under the rubric for structural defects or significant injury reports.

Plain-English summary

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

The recall covers a total of 1,598 units, with 824 located in the United States and 774 outside the US. The affected units are distributed across numerous US states and international locations. The source text does not specify reported injuries or illnesses associated with this defect.

Consumers and healthcare facilities should contact GE Healthcare for instructions on how to address the potential hazard. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
RFX
Manufacturer
GE Healthcare, LLC

Distribution

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 →