GE Healthcare Recalls CRT Monitors Due to Potential Fall Hazard
GE Healthcare is recalling specific CRT monitors due to the potential for the units to fall. The recall affects multiple system models including ADVANTX and Prestige.
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 involves a risk-of-harm product (falling equipment) 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 specific CRT monitors due to the potential for the aged units to fall. The affected products include Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX, and Innova 2000 systems.
The recall covers a total of 1,598 units, with 824 units distributed in the United States and 774 units distributed outside the US. The source text does not report any specific injuries or illnesses associated with this defect.
Consumers and healthcare facilities should contact GE Healthcare for instructions on how to address the potential fall hazard associated with these monitors.
The recalled product
- Product
- ADVANTX LCLP+
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — CRT Monitors
- Hazard
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 →Related recalls
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