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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 13,202
Distribution
Part of a larger recall action
This product is one of 2 recalled by Spacelabs Healthcare, Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Spacelabs Healthcare, Ltd.
See all →- HighCardiology records system recalled over data saved to the wrong patient
FDA (Devices) · 2025-11-12
- ModerateECG Patch Recorder Serial Number Mismatch - Eclipse Mini
FDA (Devices) · 2024-12-25
- ModerateSpacelabs Sentinel V10 and V11 Software Upgrade Recall
FDA (Devices) · 2020-12-16
- SevereSpacelabs Arkon Anesthesia Delivery System Recalled for Ventilation Failure Risk
FDA (Devices) · 2018-08-22
- SevereSpacelabs Arkon Anesthesia Workstation Recalled for Mechanical and Display Failures
FDA (Devices) · 2017-11-29
Similar recalls
- ModerateSpacelabs Healthcare Recalls Pathfinder SL Holter Analyzer Software
FDA (Devices) · 2012-06-27
- HighSpacelabs Xhibit Telemetry Receiver Recall for Signal Loss
FDA (Devices) · 2016-04-27
- ModerateSpacelabs CardioCall ECG Event Recorders Recalled for Battery Defect
FDA (Devices) · 2015-11-04
- ModerateSpacelabs elance Vital Signs Monitor Recalled Due to Sensor Connection Failure
FDA (Devices) · 2013-11-20
- HighSpacelabs Telemetry Receiver Recall Due to Loss of Patient Monitoring
FDA (Devices) · 2018-02-14
- SevereSpacelabs Xhibit Central Recall for Audio Alarm Loss After Power Failure
FDA (Devices) · 2020-06-10