# FDA recall Z-1044-2025

> **GE Medical Systems, LLC** · Class II · device recall initiated 2025-01-28.

## Product

Discovery XR656HD. X-Ray imaging system.

## Reason for recall

The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.

## Distribution

Worldwide Distribution: US (nationwide) including Puerto Rico and OUS (foreign) countries to: Canada, Chile, China, Colombia, Coast Rica, Croatia, Cyprus, Czech Republic, Czechia, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Gibraltar, Greece, Honduras, Hong Kong, Hungary, Iceland, Indonesia, Iraq, Ireland, Italy, Jamaica, Japan, Jordan, Kenya, Korea (Republic of) Kuwait, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Vietnam.

## Key facts

- **Recall number:** Z-1044-2025
- **Recalling firm:** GE Medical Systems, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-28
- **Report date:** 2025-02-12

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Waukesha, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1044-2025

## Citation

> AI Analytics. FDA recall Z-1044-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1044-2025. Source: US FDA. Licensed CC0.

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