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.
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.
The system's automatic exposure control (AEC) limit may not properly stop further imaging once reached. Users can continue taking additional exposures without acknowledging the limit, potentially causing overexposure. A message appears on the screen when the limit is reached, but users may not recognize the need to stop.
Healthcare facilities using the Optima XR646 HD X-Ray system are likely affected. Medical staff and patients using this equipment may be at risk if the system is not properly monitored.
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.
Look for the AEC limit message on the screen when the exposure limit is reached.
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.
Check for the Optima XR646 HD X-Ray imaging system with GTIN 00195278526892.
The recall does not specify a remedy, so no action is required beyond checking the system status.
We’ve drafted a message you can send GE Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1046-2025 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-1046-2025 from GE Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
