Agency classClass IIOur severity:High FDA (Devices)·Z-0853-2021·Announced 2021-01-20

GE Healthcare Recalls NM/CT 850 Systems Due to Loose Rotor Bearing Screws

GE Healthcare is recalling 24 NM/CT 850 systems because loose rotor bearing screws caused a bearing to release in one field unit.

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 3/5 (High).

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 structural defect in a medical device (loose screws leading to bearing release) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

GE Healthcare, LLC is recalling 24 units of the GE NM/CT 850 system, Model Number H3907AD. These systems are intended for general Nuclear Medicine imaging procedures to detect radioisotope tracer uptake in the patient body. The affected units were distributed worldwide.

The recall was initiated because GE Healthcare became aware that rotor bearing screws were found loose on one detector in the field. This issue led to the release of one of the four rotor bearings in that specific detector. The source text does not report any patient injuries or illnesses associated with this defect.

Healthcare facilities should contact GE Healthcare for instructions on how to address the loose screws and ensure the integrity of the rotor bearings. The recall covers specific serial numbers listed in the agency's documentation.

The recalled product

Product: GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Imaging Equipment
Hazard: mechanical-failure
structural-defect
Affected units: 24

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Serial numbers: 85EY67048
850Y61018
85EY67045
85EY67046
85EY67047
850Z61038
85EY67043
850Z61042
85EZ67056
850Z61043
850Z61044
850Z61045
850Z61041
850Z61039
850Z61040
85EZ67055
85EZ67053
85EZ67054
850Y61019
85EY67044

Distribution

Distribution scope not specified by the agency.

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 →

Same manufacturer · GE Healthcare, LLC

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Same hazard · mechanical failure