The Recall Desk
SevereFDA (Devices)·Z-0184-2015·Announced 2014-11-19

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.

What this means for you

Illness, injury, or structural failure has been reported. 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, H
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Nuclear Medicine Imaging
Hazard
Affected units
2,479

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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

Same manufacturer · GE Healthcare, LLC

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Same hazard · falling object

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