The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0907-2017·Announced 2017-01-04

GE Healthcare Recalls CRT Monitors Due to Potential Fall Hazard

GE Healthcare is recalling specific CRT monitors due to a risk that aged units may fall. The recall affects multiple imaging system models.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 is classified as FDA Class II and involves a risk of physical injury from falling equipment, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Healthcare, LLC is conducting a recall of specific Cathode Ray Tube (CRT) monitors due to the potential for aged units to fall. The affected monitor models include Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX, and Innova 2000 systems.

The recall involves a total of 1,598 units, with 824 located in the United States and 774 located outside the US. The affected units are distributed across numerous US states and international locations. Specific lot and serial numbers for the affected units are listed in the official recall documentation.

This recall is classified as FDA Class II. Consumers and healthcare facilities should check their equipment against the specific serial and lot numbers provided in the official recall notice to determine if their units are affected.

The recalled product

Product
ADVANTX LCN+
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Imaging Monitor
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

See all →

Same hazard · falling object

See all →

Similar recalls