The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2194-2017·Announced 2017-06-21

GE Healthcare Discovery NM/CT 670 X-ray Systems Recalled for Scan Timing Defect

GE Healthcare is recalling Discovery NM/CT 670 X-ray systems because a defect may cause scans to start before a prescribed delay completes.

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 medical device defect that could lead to unintended scan initiation, representing a risk-of-harm product where injury has not yet been reported, consistent with the High severity criteria.

Plain-English summary

GE Healthcare, LLC is recalling approximately 10,884 units of the Discovery NM/CT 670, 670 Pro, and 670 ES X-ray systems. The recall was initiated because an issue was identified that can result in a scan starting before the prescribed delay has completed.

The affected products were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in numerous international countries. The source text does not specify specific lot numbers or dates of manufacture.

Consumers and healthcare facilities should contact GE Healthcare for further instructions on how to address this issue. The source text does not provide specific contact details or remediation steps.

The recalled product

Product
GE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES X-ray system
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Imaging Equipment
Hazard
Affected units
10,884

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)

  • n/a

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 16 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 16 products in this recall →

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