ECG Patch Recorder Serial Number Mismatch - Eclipse Mini
Spacelabs Healthcare is recalling the Eclipse Mini ECG patch recorder because incorrect serial numbers may be programmed into devices, causing a mismatch between the physical label and internal serial number.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II classification with no reported illnesses, injuries, or deaths. The hazard is a serial number identification and labeling error without reported harm, matching the rubric criterion for score 2 (minor labeling errors, precautionary recalls).
Plain-English summary
The Eclipse Mini Model 98900 is a portable, non-invasive continuous ambulatory ECG patch recorder intended to record a patient's electrocardiogram. Approximately 1,779 devices are affected by this recall.
Due to a manufacturing error, the incorrect device serial number was potentially programmed into the device. This causes the physical serial number label on the device to potentially not match the serial number programmed into the device.
The affected devices were manufactured between May 2021 and November 2024 and have been distributed throughout the United States and internationally.
The recalled product
- Product
- Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient s electrocardiogram.
- Manufacturer
- Spacelabs Healthcare, Ltd.
- Hazard
- serial-number-mismatch
- mis-labeling
Distribution
Distributed in 21 states:
- AR
- CA
- CO
- DE
- FL
- LA
- MA
- MI
- MN
- MT
- NC
- NE
- OH
- OR
- PA
- TN
- TX
- UT
- VA
- WA
- WI
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