The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0023-2014·Announced 2013-10-23

GE Optima CT660 Recalled for Potential Series UID Generation Error

GE Healthcare is recalling Optima CT660 scanners because the DMPR and Screen Save functions may generate duplicate Series UIDs, potentially causing PACS systems to combine patient series incorrectly.

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 hazard involves a software error that could lead to incorrect image association, which is a moderate risk of harm without reported injuries.

Plain-English summary

GE Healthcare, LLC is recalling 380 units of the Optima CT660, Brivo CT385, Discovery PET/CT 610, and Discovery PET/CT 710 scanners. The recall involves a potential safety issue related to the DMPR function and Screen Saved Images. The affected units were distributed worldwide, including 52 units in the United States and 328 units outside the US.

The issue is that the DMPR and Screen Save functionality may generate the same Series UID for different series. Some Picture Archiving and Communication Systems (PACS) use only the Series UID to combine series under a patient. This could result in the incorrect combination of patient series, potentially leading to diagnostic errors.

Healthcare facilities should contact GE Healthcare for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — CT Scanner
Hazard

Distribution

Distributed nationwide across the United States.

The notice also names 22 states specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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