The Recall Desk
HighFDA (Devices)·Z-1045-2025·Announced 2025-02-12

GE Discovery XR656 HD X-ray system AEC control malfunctions during imaging

GE Medical Systems is recalling the Discovery XR656 HD X-ray imaging system due to a malfunction in the Automatic Exposure Control (AEC) feature. The defect allows continued X-ray exposure beyond intended limits without requiring operator acknowledgment.

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: FDA Class II medical device with malfunction of a radiation dose-control safety feature (AEC). No reported illnesses or injuries, but the defect creates risk of unintended patient radiation exposure by allowing exposure beyond the designed safety limit.

Plain-English summary

The Discovery XR656 HD is an X-ray imaging system used in medical facilities for diagnostic imaging. Approximately 3,149 units worldwide (1,697 in the United States and 1,452 outside the US) are affected.

The Automatic Exposure Control (AEC) system is designed to limit X-ray exposure to ensure patients receive the minimum necessary radiation dose for diagnostic imaging. Due to the defect, operators can continue X-ray exposure after reaching the AEC limit without being prompted to acknowledge or adjust their exposure technique. While a message appears on the screen when the AEC limit is reached, the system does not prevent continued exposure, potentially resulting in unintended patient radiation doses.

The affected devices were distributed worldwide to healthcare facilities including locations in the United States (including Puerto Rico), Canada, Mexico, Europe, Asia, South America, Africa, and the Middle East.

Facilities using the Discovery XR656 HD should contact GE Medical Systems immediately for instructions on addressing this defect. Operators should be made aware of the AEC malfunction and take appropriate measures to ensure radiation doses remain within intended limits.

The recalled product

Product
Discovery XR656 HD. X-Ray imaging system.
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Diagnostic Imaging / X-ray
Hazard
  • excessive-radiation-exposure
  • aec-control-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 (1)

  • Definium Tempo (GTIN: 00195278118356) Definium Tempo Pro (GTIN: 00195278070265)

Distribution

Distributed nationwide across the United States.

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