The Recall Desk
SevereFDA (Devices)·Z-0905-2017·Announced 2017-01-04

GE Healthcare Recalls ADVANTX LCA Systems Due to CRT Monitor Fall Risk

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

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 is classified as FDA Class II and involves a structural defect (falling monitors) that poses a risk of significant injury, meeting the criteria for a Severe rating.

Plain-English summary

GE Healthcare, LLC is conducting a Class II recall of ADVANTX LCA and other medical imaging systems, including Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, 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 international locations, including Canada, the United Kingdom, and Germany. Specific lot and serial numbers are listed in the recall documentation.

This 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. Consumers and healthcare facilities should contact GE Healthcare for instructions on how to address the potential hazard.

The recalled product

Product
ADVANTX LCA
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 →