The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1260-2019·Announced 2019-05-08

GE Discovery NM/CT 670 ES Recalled for Potential Detector Screw Issue

GE Healthcare is recalling three Discovery NM/CT 670 ES systems because detector screws may not have been secured correctly during installation.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a potential loss of design redundancy without reporting any injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling three units of the Discovery NM/CT 670 ES system. This medical device is a combination of Nuclear Medicine (NM) and Computed Tomography (CT) systems intended for use by trained health professionals to aid in detecting, localizing, and diagnosing diseases and organ function.

The recall was initiated because, during the installation of certain systems delivered with dismounted detectors, some detector screws may not have been secured correctly. This issue could lead to the possible loss of one detector mounting design redundancy.

The affected units were distributed in the US and Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, and the UK. The specific units are identified by the following serial numbers: ESDX35020, ESPX54001, and ESPY54002.

The recalled product

Product
Discovery NM/CT 670 ES Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma…
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Imaging Equipment
Hazard
Affected units
3

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 (1)

  • Mfg. Lot or Serial # System ID Model

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 10 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 10 products in this recall →

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