The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2193-2017·Announced 2017-06-21

GE Healthcare Discovery ML X-ray System Recalled for Scan Timing Defect

GE Healthcare is recalling 10,884 Discovery ML 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 is classified as FDA Class II. The hazard involves a functional defect in a medical device that could lead to unintended radiation exposure or procedural errors, representing a risk of harm where injury has not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling 10,884 units of the Discovery ML X-ray system. 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 other countries such as Japan, Mexico, and the United Kingdom. The source text does not specify a particular lot number or date of manufacture.

Consumers and healthcare facilities should contact GE Healthcare for further instructions on how to address this defect. The source text does not report any specific injuries or illnesses associated with this issue.

The recalled product

Product
GE Healthcare Discovery Ml X-ray system
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Diagnostic Imaging
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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