Agency classClass IIOur severity:High FDA (Devices)·Z-1043-2025·Announced 2025-02-12

X-Ray imaging systems may allow radiation exposure beyond safety limits

GE Medical Systems is recalling Definium 656HD and Discovery XR656HD X-Ray systems due to an Automatic Exposure Control defect that may allow radiation exposure to exceed intended safety limits.

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: This is an FDA Class II medical device recall involving a safety feature failure in radiation exposure control. No illnesses or injuries have been reported. The defect creates a risk of unintended radiation overexposure, classified as a risk-of-harm situation without reported harm.

Plain-English summary

GE Medical Systems is recalling Definium 656HD and Discovery XR656HD X-Ray imaging systems. These systems have a defect in the Automatic Exposure Control (AEC) feature, a safety mechanism designed to limit radiation exposure.

With the defect, operators can continue taking X-Ray exposures after the AEC limit is reached without needing to acknowledge or adjust their technique. Although the system displays a message when the limit is reached, operators may proceed with additional exposures without intervention, potentially resulting in unintended radiation overexposure to patients or operators.

The recall affects approximately 3,149 systems worldwide, including 1,697 units in the United States and Puerto Rico. Systems have been distributed internationally to Canada, Mexico, Chile, China, Japan, South Korea, and numerous other countries.

Users should review the recall information provided by GE Medical Systems and consult their facility's radiation safety procedures regarding proper use of the AEC feature. Contact GE Medical Systems for specific guidance on this recall.

The recalled product

Product: Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.
Manufacturer: GE Medical Systems, LLC
Category: Medical Device — Radiology Equipment
Hazard: radiation-overexposure
safety-feature-failure

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 (3)

GTINs: 00840682138598
00195278840226
00840682136709)

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 4 recalled by GE Medical Systems, 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 4 products in this recall →

Same manufacturer · GE Medical Systems, LLC

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