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GE Medical Systems, LLC recalls Discovery XR656HD. X-Ray imaging system.
Recalled February 12, 2025 · FDA recall Z-1044-2025 · GE Medical Systems
Hazard
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. · FDA Class II
Units
3149 (1697 US; 1452 OUS)
Sold at
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.
Description
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.
Product
Discovery XR656HD. X-Ray imaging system.
Manufacturer(s)
GE Medical Systems, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →