The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1266-2019·Announced 2019-05-08

GE Healthcare Recalls Optima NM/CT 640 Systems for Detector Screw Issue

GE Healthcare is recalling 35 Optima NM/CT 640 systems because detector screws may not have been secured correctly, potentially compromising mounting redundancy.

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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

GE Healthcare, LLC is recalling 35 units of the Optima NM/CT 640 system. These systems are intended for general nuclear medicine imaging procedures and include a CT component for attenuation correction and anatomical localization. The recall covers units distributed in the US and several international countries, including Austria, Canada, France, Germany, and the UK.

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

No specific instructions for consumers are provided in the source text, as these are medical devices typically managed by healthcare facilities. Affected units are identified by specific serial numbers and model codes listed in the recall documentation.

The recalled product

Product
Optima NM/CT 640 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 using a variety of scanning…
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Imaging Equipment
Hazard
Affected units
35

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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