CLASS II ONGOING Device recall · Reported 12 Feb 2025 · FDA Enforcement Report

Definium 656HD & Discovery XR656HD (GTINs recalled by GE Medical Systems

GE Medical Systems is recalling Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709), distributed nationwide in the US. The recall was initiated on 28 Jan 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTINs: 00840682138598, 00195278840226, 00840682136709)

Quantity recalled3149 (1697 US; 1452 OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1043-2025
FDA event ID: 96208
Recalling firm: GE Medical Systems, Waukesha, WI
Classification: Class II
Status: Ongoing
Recall initiated: 28 Jan 2025
FDA classified: 3 Feb 2025
Reported: 12 Feb 2025
Type: FDA Mandated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

28 Jan 2025	Recall initiated by company
3 Feb 2025	Classified by FDA	+6 days
12 Feb 2025	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.

Where it was distributed

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.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

GTINs: 00840682138598, 00195278840226, 00840682136709)

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 96208

This product is part of a recall event; the main page for the event is Optima XR646 HD. X-Ray imaging system recalled by GE Medical Systems.

Reported	Class	Recall	Company	Reason	Where
12 Feb 2025	CLASS II	Optima XR646 HD. X-Ray imaging system recalled by GE Medical Systems	GE Medical Systems	Other	Nationwide
12 Feb 2025	CLASS II	Discovery XR656 HD. X-Ray imaging system recalled by GE Medical Systems	GE Medical Systems	Other	Nationwide
12 Feb 2025	CLASS II	Discovery XR656HD recalled by GE Medical Systems	GE Medical Systems	Other	Nationwide

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