GE Medical Systems, LLC has recalled 3,149 units of various X-ray imaging systems, including the Definium 656HD, Discovery XR656HD, Definium Tempo, Definium Tempo Pro, and Optima XR646 HD models. The recall is due to a software issue where the system allows a user to continue taking exposures after the Automatic Exposure Control (AEC) limit is reached without requiring any acknowledgment or adjustment of exposure techniques. While a warning message appears on the screen when the limit is reached, the system's failure to block subsequent exposures could lead to unintended radiation levels for patients. Approximately 1,697 of the affected units were distributed in the United States, with no incidents or injuries reported to date.
The software defect allows medical staff to proceed with additional X-ray exposures even after the safety limit has been triggered, without being forced to manually adjust or acknowledge the setting. This creates a risk of exposing patients to higher levels of radiation than intended.
Recall Number Z-1043-2025
Recall Number Z-1044-2025
Recall Number Z-1045-2025
Recall Number Z-1046-2025
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.