GE Healthcare Recalls MRI Scanners Due to Cradle Release Malfunction
GE Healthcare is recalling 1,548 MRI scanners because a malfunctioning cradle release mechanism could delay or impede patient egress from the system.
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 where the mechanism could impede patient egress, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
GE Healthcare, LLC is recalling 1,548 units of specific Discovery and Optima MRI scanner models due to a potential safety issue. The affected devices are whole body magnetic resonance scanners indicated for use as diagnostic imaging devices.
The recall is being issued because patient egress from the system can be delayed or impeded if the cradle release handle and/or cradle release block mechanism malfunctions or becomes misaligned. This condition could make the safe removal of the patient from the system difficult.
The affected units were distributed worldwide, including in the United States (excluding North Dakota, Rhode Island, and Wyoming, but including DC, Guam, and Puerto Rico) and numerous international countries. Consumers and healthcare facilities should contact GE Healthcare for further instructions on how to address this issue.
The recalled product
- Product
- GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discovery MR750w equipped with the GEM option products. Affected devices are whole body magnetic resonance scanners indicated for use as a…
- Manufacturer
- GE Healthcare, LLC
Distribution
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