The Recall Desk
HighFDA (Devices)·Z-1044-2025·Announced 2025-02-12

Medical X-Ray System Permits Bypass of Radiation Exposure Control

GE Medical Systems' Discovery XR656HD X-Ray imaging systems can allow radiation exposures to exceed the Automatic Exposure Control limit without blocking further exposure. Approximately 3,149 units are affected worldwide, including 1,697 in the United States.

What this means for you

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 defect in a critical safety-control system (Automatic Exposure Control) that allows radiation exposure to exceed intended limits without operator intervention. No injuries or illnesses have been reported. The defect constitutes a risk-of-harm product where injury has not yet been reported, meeting the Score 3 threshold.

Plain-English summary

The Discovery XR656HD X-Ray imaging system, manufactured by GE Medical Systems, LLC, has a defect in its Automatic Exposure Control (AEC) system. The AEC is designed to limit radiation exposure by preventing additional exposures once a safety threshold is reached. However, the system does not actually prevent further exposure.

When the AEC limit is reached, the system displays a message on the screen but does not block the operator from taking additional X-Ray exposures. This means users can inadvertently exceed the intended radiation exposure limits without being forced to acknowledge the limit or adjust their technique.

Approximately 3,149 Discovery XR656HD systems are affected, including 1,697 in the United States and 1,452 distributed internationally to numerous countries. Facilities using affected equipment should refer to the FDA recall notice and contact GE Medical Systems for guidance on addressing this defect.

The recalled product

Product
Discovery XR656HD. X-Ray imaging system.
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Imaging Equipment
Hazard

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 (2)

  • GTINs: 00840682142175
  • 00840682142168

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 →

Related recalls

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Same hazard · radiation exposure

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