Eclipse PRO Holter Recorders Recalled for Serial Number Mismatch
Spacelabs Healthcare recalls 13,202 Eclipse PRO Holter recorders due to manufacturing error where the programmed serial number may not match the physical label. Affected devices were manufactured between April 2021 and November 2024.
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: This FDA Class II device recall involves a labeling error where the programmed serial number may not match the physical label. No illnesses or injuries have been reported, and the issue is a documentation discrepancy rather than a functional safety hazard. Per the severity rubric, minor labeling errors without reported illness are classified as Moderate (2).
Plain-English summary
Spacelabs Healthcare is recalling 13,202 units of the Eclipse PRO REF 98700, a portable Holter recorder used to record patients' ambulatory electrocardiograms (ECGs). A manufacturing error resulted in an incorrect device serial number potentially being programmed into the device, causing the programmed serial number to possibly not match the physical serial number label on the device.
All affected units were manufactured between April 2021 and November 2024.
The recalled devices were distributed throughout the United States and internationally across more than 40 countries and territories.
Patients and healthcare providers with these devices should contact Spacelabs Healthcare, Ltd., for further guidance regarding this recall.
The recalled product
- Product
- Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.
- Manufacturer
- Spacelabs Healthcare, Ltd.
- Hazard
- serial-number-mismatch
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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