GE Healthcare Recalls Precision 500D Systems Due to Monitor Fall Risk
GE Healthcare is recalling Precision 500D and other systems because aged CRT monitors may fall.
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 High severity criteria.
Plain-English summary
GE Healthcare, LLC is conducting a recall of Precision 500D systems, along with Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, ADVANTX, and Innova 2000 systems. The recall is due to the potential fall of aged CRT monitors.
A total of 1,598 units are affected, with 824 in the United States and 774 outside the US. The products were distributed across numerous US states and international locations. Specific lot or serial numbers are listed in the agency record.
Consumers and healthcare facilities should contact GE Healthcare for instructions on how to address the potential hazard.
The recalled product
- Product
- Precision 500D
- 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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