GE Discovery NM/CT 670 Imaging System Recalled for Loose Fasteners
GE Healthcare is recalling 255 Discovery NM/CT 670 systems because loose fasteners may cause a portion of the system to fall onto patients during scans.
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 defect (loose fasteners) in a medical device that could cause a component to fall onto a patient, posing a risk of significant injury, which aligns with the 'Severe' criteria for structural defects or significant injury reports.
Plain-English summary
GE Healthcare, LLC is recalling 255 units of the Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. The affected models include H3100NA, H3100PP, H3100RA, H2401LS, H2401LZ, and H2402LS. These systems are medical tools used by trained healthcare professionals to aid in detecting, localizing, and diagnosing diseases and organ function.
The recall is issued due to a potential safety issue where loose fasteners securing the camera to the gantry could cause a portion of the system to fall onto a patient during a scan. GE is updating its Preventative Maintenance procedure and schedule to include an additional check for loose fasteners on Nuclear Medicine systems.
The affected units were distributed worldwide, including the United States (nationwide, Guam, Puerto Rico, and DC) and numerous international countries. Healthcare facilities should contact GE Healthcare to arrange for the updated preventative maintenance checks.
The recalled product
- Product
- Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, H3100PP, H3100RA, H2401LS, H2401LZ, H2402LS. Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare…
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 255
Distribution
Part of a larger recall action
This product is one of 6 recalled by GE Healthcare, LLC 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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