The Recall Desk
SevereFDA (Devices)·Z-0188-2015·Announced 2014-11-19

GE Optima NM/CT 640 Recalled for Loose Camera Fasteners

GE Healthcare is recalling 29 Optima NM/CT 640 systems because loose fasteners could cause the camera 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 on 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 29 units of the Optima NM/CT 640 system, specifically Models H3100YA and H3100YC. These systems are used for general nuclear medicine imaging procedures and include a CT component for attenuation correction and anatomical localization.

The recall is being 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 for instructions on how to resolve the issue.

The recalled product

Product
Optima NM/CT 640, Models H3100YA, H3100YC. Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system u
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Imaging Equipment
Hazard
Affected units
29

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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