GE Healthcare Recalls Infinia Nuclear Medicine Systems Due to Mechanical Failure Risk
GE Healthcare is recalling Infinia Nuclear Medicine Systems because a mechanical defect could cause the detector to slide, posing a risk to patients and 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural/mechanical defect in a medical device that could cause the detector to slide, posing a risk of injury to patients and operators, which aligns with the 'Severe' criteria for significant injury risk or structural defects.
Plain-English summary
GE Healthcare, LLC is recalling the Quasar Nuclear Medicine System, Hawkeye Option, and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera, including all Infinia systems in all configurations. The recall involves 2,180 units distributed worldwide, including the United States and numerous international markets.
The recall is due to accelerated fatigue of the lateral axis motion subsystem, which could result in mechanical failure causing the detector to slide. This defect may impact patients and operators.
Healthcare facilities should contact GE Healthcare for instructions on how to address the defect. The source text does not specify a deadline or additional remediation steps beyond the recall notification.
The recalled product
- Product
- GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera. Nuclear Medicine imaging systems. Recall includes all Infinia systems, all configurations.
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 2,180
Distribution
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