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FDA (Device enforcement)Recalled 2025-01-28class ii

GE Medical Systems, LLC: Discovery XR656HD. X-Ray imaging system.

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.

Details from the source

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, L Quantity: 3149 (1697 US; 1452 OUS) Lot/code info: GTINs: 00840682142175, 00840682142168

UPC codes

00840682142175, 00840682142168

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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