GE Healthcare Infinia Nuclear Medicine Systems Recalled for Loose Fasteners
GE Healthcare is recalling Infinia nuclear medicine systems because loose fasteners could cause a portion of the system to fall onto a patient during a scan.
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) that could cause a heavy component to fall onto a patient, posing a significant injury risk, which aligns with the 'Severe' criteria for structural defects or significant injury reports.
Plain-English summary
GE Healthcare, LLC is recalling 2,479 units of Infinia nuclear medicine systems, including various Infinia, Hawkeye, and Quasar models. The recall is 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 the patient during a scan.
The affected devices are distributed worldwide, including the United States (nationwide, Guam, Puerto Rico, and DC) and numerous international countries. GE Healthcare is updating the Preventative Maintenance procedure and schedule, adding an additional check for loose fasteners on these Nuclear Medicine systems.
Healthcare facilities should contact GE Healthcare for instructions on how to update the maintenance procedures and perform the necessary checks to secure the fasteners.
The recalled product
- Product
- GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye 4, Infinia II VC, Infinia II VC Hawkeye, and Infinia II VC Hawkeye 4) Models: H3000WC, H3000WD, H3000WE, H3000WM, H3000WN, H3000WP, H3000WR, H3000WT, H3000WW, H3000WY…
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 2,479
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.
See all 6 products in this recall →Related recalls
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