GE Healthcare Recalls SPECT Imaging Systems Due to Potential Patient Contact Hazard
GE Healthcare is recalling four models of nuclear medicine and CT imaging systems because the detector may contact a patient's elbow during specific SPECT scans.
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 (medical device) where injury has not yet been reported, which corresponds to a score of 3 (High) per the rubric.
Plain-English summary
GE Healthcare, LLC is recalling the Discovery NM/CT 670, Discovery NM 630, Optima NM/CT 640, and Brivo NM 615 imaging systems. The recall involves 464 units distributed worldwide, including 143 units in the United States and 321 units in other countries.
The recall is due to a potential safety issue where the detector of the imaging system may come into contact with a patient's elbow. This risk is associated with SPECT scan procedures used for pulmonary imaging that utilize 450 angular steps. The source text does not report any injuries or illnesses resulting from this issue.
Healthcare professionals using these systems should be aware of the potential for physical contact between the equipment and the patient during the specified scanning protocols. The recall covers systems distributed in the US and numerous international locations.
The recalled product
- Product
- GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The GE Discovery NMJCT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ functio
- Manufacturer
- GE Healthcare, LLC
- Hazard
Distribution
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