GE Healthcare Precision MPi Fluoroscopic Imaging Systems Recalled for Monitor Fall Risk
GE Healthcare is recalling Precision MPi fluoroscopic imaging systems because a monitor fell from its suspension, posing a risk of injury to patients or operators.
What this means for you
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 medical devices.
Plain-English summary
GE Healthcare is recalling Precision MPi fluoroscopic imaging systems due to a reported incident where a monitor fell from its suspension. The recall also affects single and dual LCD monitor suspensions used on Precision 500D Classical R & F systems, Precision RXi 23A/32A Analog Systems, and Precision RXi Digital systems.
A fall of a monitor could result in an injury to a patient or operator. The recall involves 788 units, with 701 distributed in the US and 87 outside the US. Distribution was worldwide, including the US, Australia, Canada, Germany, the United Kingdom, and other listed countries.
Healthcare facilities should contact GE Healthcare for instructions on how to address the defect. Specific serial numbers for the affected units are listed in the official recall documentation.
The recalled product
- Product
- GE Healthcare, Precision MPi fluoroscopic imaging systems.
- Manufacturer
- GE Healthcare
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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