Spacelabs Healthcare, Ltd. has issued a voluntary recall for 14,981 Eclipse PRO (Model 98700) and Eclipse Mini (Model 98900) Holter recorders due to a manufacturing error. The serial number programmed into the device's software may not match the physical serial number label on the exterior of the device. This discrepancy was discovered during manufacturing and affects units produced between April 2021 and November 2024. While no injuries have been reported, the mismatch can lead to identification errors during clinical use.
The mismatch between internal and external serial numbers could cause patient diagnostic data to be incorrectly identified or associated with the wrong device record. This creates a risk of administrative errors in patient medical records or difficulties in tracking device maintenance and history.
Physical serial number label on the device might not match the serial number programmed into the device software.
Internal programmed serial number may not match the physical label.
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
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