The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2191-2017·Announced 2017-06-21

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

GE Healthcare is recalling Discovery ML DR X-ray systems because a software issue 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, and the hazard involves a risk of harm (premature scan initiation) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

GE Healthcare, LLC is recalling approximately 10,884 units of the Discovery ML DR X-ray system. The recall was initiated after an issue was identified that can result in a scan starting before the prescribed delay has completed.

The affected units were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in numerous other countries. The source text does not specify a particular lot number or date of manufacture for the affected units.

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 a deadline for action.

The recalled product

Product
GE Healthcare Discovery Ml DR 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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