GE Healthcare Recalls Legacy Systems Due to CRT Monitor Fall Risk
GE Healthcare is recalling Legacy and other imaging systems because aged CRT monitors may fall. The recall covers 1,598 units distributed in the US and internationally.
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 monitors) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
GE Healthcare, LLC is conducting a recall of Legacy, Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Precision 500D, ADVANTX, and Innova 2000 systems. 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 systems were distributed to various states in the US and numerous countries internationally.
No specific consumer actions are detailed in the source text beyond the identification of the recall. Users of these systems should be aware of the potential hazard associated with the CRT monitors.
The recalled product
- Product
- Legacy
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Imaging Systems
- 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.
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