GE Healthcare Precision 500D Monitor Suspension Recall
GE Healthcare is recalling Precision 500D and related fluoroscopic systems because monitor suspensions may fail, posing a risk of injury to patients or operators.
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 monitor) where injury has not yet been reported, fitting the 'High' severity criteria for potential injury without confirmed harm.
Plain-English summary
GE Healthcare is recalling the Precision 500D Classical R & F system, Precision RXi 23A/32A Analog System, Precision RXi Digital system, and Precision MPi fluoroscopic imaging systems. The recall involves the single and dual LCD monitor suspensions used on these devices.
The recall was initiated after a reported incident where a monitor fell from its suspension. The source notes that a fall of a monitor could result in an injury to a patient or operator.
The recall affects 788 units, with 701 distributed in the US and 87 outside the US. Distribution was worldwide, including the US nationwide (including GU and DC) and 22 other countries. Users should contact GE Healthcare for instructions on how to address the defect.
The recalled product
- Product
- GE Healthcare Precision 500D Classical R & F system.
- Manufacturer
- GE Healthcare
- Hazard
Distribution
Part of a larger recall action
This product is one of 4 recalled by GE Healthcare 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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