Lower riskMedical device recall · FDA · Published January 28, 2025
GE Optima XR646 HD X-Ray System: Risk of Overexposure After AEC Limit
GE Medical Systems recalls Optima XR646 HD X-Ray systems that may allow continued imaging after reaching exposure limits without user acknowledgment, potentially causing overexposure. Affected units have GTIN 0019527:526892.
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.
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Contact the company
📍Recalling firmGE Medical Systems, LLC3000 N Grandview Blvd · Waukesha, WI 53188-1615
✎ GovInfoNow plain-language explainer
GE Medical Systems is recalling its Optima XR646 HD X-Ray imaging systems because the device may allow users to take additional exposures after reaching the automatic exposure control limit without any action. This could lead to overexposure risks if not properly managed. Read more at govinfonow.com/recall/53019-ge-optima-xr646-hd-x-ray-system-risk-of-overexposure.
“GE Optima XR646 HD X-Ray System: Risk of Overexposure After AEC Limit.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/53019-ge-optima-xr646-hd-x-ray-system-risk-of-overexposure. Based on FDA recall #Z-1046-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1046-2025%22&limit=1).
The FDA announced on Jan. 28, 2025, that GE Medical Systems LLC is recalling the Optima XR646 HD X-Ray imaging system because users can continue exposures past the Automatic Exposure Control limit without acknowledgment. The agency classified the recall as Class II and ongoing.
How to tell if you have it
Brand: GE Medical Systems
Product: Optima XR646 HD X-Ray imaging system
UPC: 00195278526892
The hazard
The device allows users to take the next exposure after reaching the Automatic Exposure Control limit without taking further actions to acknowledge or adjust exposure techniques. A message still appears on the screen when the limit is reached, but the system does not prevent continued use.
Context
GovInfoNow's records show GE Medical Systems, LLC has had 27 other recalls since March 30, 2018. Recent brand-specific actions include a June 5, 2026 recall of the GE Optima XR200amx Mobile Radiography System for column safety risks and a May 1, 2026 notice regarding canopy soffit issues. Other recent recalls of similar products include the AGFA DR 800 X-Ray System Recall (Nov. 18, 2025), Siemens ARTIS pheno and Icono Biplane Recalls (March 10, 2026), and Philips Spectral CT 7500 Scanner recall (Aug. 18, 2026).
How to tell if you have this one
Check for the Optima XR646 HD X-Ray imaging system with GTIN 00195278526892. This model was sold by GE Medical Systems for medical imaging use.
Brand
GE Medical Systems
Product
Optima XR646 HD. X-Ray imaging system
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
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.
Look for the AEC limit message on the screen when the exposure limit is reached.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 15 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The recall indicates a potential risk of overexposure if users continue imaging after reaching the AEC limit, but the hazard is not described as causing serious injury.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1046-2025 (January 28, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1046-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.