GE Healthcare Precision RXi Digital System Monitor Suspension Recall
GE Healthcare is recalling Precision RXi Digital systems because a monitor fell from its suspension, posing an injury risk 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 is classified as FDA Class II and involves a risk of physical injury (falling monitor) to patients or operators, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
GE Healthcare is recalling the Precision RXi Digital system due to a reported incident where a monitor fell from its suspension. The recall also affects single and dual LCD monitor suspensions used on the Precision 500D Classical R & F system, Precision RXi 23A/32A Analog System, and Precision MPi fluoroscopic imaging systems.
The hazard is that a falling monitor could result in an injury to a patient or operator. The recall covers 788 units, with 701 distributed in the US and 87 outside the US. Distribution was worldwide, including the US, Australia, Canada, Germany, and other listed countries.
Consumers and healthcare facilities should contact GE Healthcare for instructions on how to address the defect. The source text does not specify a particular action such as stopping use, but the recall is active for the identified serial numbers.
The recalled product
- Product
- GE Healthcare Precision RXi Digital system
- Manufacturer
- GE Healthcare
- Category
- Medical Device — Imaging System
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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