Lower riskMedical device recall · FDA · Published November 25, 2024
Spacelabs Eclipse PRO REF 98700 Holter Recorder: Incorrect Serial Number Risk
Spacelabs recalls model 98700 portable Holter recorders made between April 2021 and November 2024 due to potential mismatch between physical and programmed serial numbers.
Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the serial number programmed into the device.
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Contact the company
📍Recalling firmSpacelabs Healthcare, Ltd.Unit B, Foxholes Centre; John Tate Road · Hertford, United Kingdom
✎ GovInfoNow plain-language explainer
Spacelabs is recalling portable Holter recorders (model 98700) made from April 2021 to November 2024 because the physical serial number label might not match the serial number programmed into the device. This mismatch could lead to incorrect identification or tracking of the device. Read more at govinfonow.com/recall/53391-spacelabs-eclipse-pro-ref-98700-holter-recorder-incorrect-serial-number.
“Spacelabs Eclipse PRO REF 98700 Holter Recorder: Incorrect Serial Number Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53391-spacelabs-eclipse-pro-ref-98700-holter-recorder-incorrect-serial-number. Based on FDA recall #Z-0684-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0684-2025%22&limit=1).
The FDA announced on November 25, 2024, that Spacelabs Healthcare is recalling the Eclipse PRO REF 98700 Holter recorder due to a manufacturing error where the programmed serial number may not match the physical label. This discrepancy affects 13,202 devices distributed in the U.S. and internationally.
How to tell if you have it
Brand: Spacelabs
Product: Eclipse PRO REF 98700
Model Number: 98700
UDI-DI code: 10841522128851
Serial Numbers: All serial numbers manufactured between April 2021 to November 2024
The hazard
According to the FDA, a manufacturing error may have caused the incorrect device serial number to be programmed into the Holter recorder. Consequently, the physical serial number label on the device might not match the serial number programmed into the device.
Context
GovInfoNow's records show Spacelabs Healthcare has issued four other recalls since October 11, 2017. Recent related actions include a September 16, 2025 recall of Sentinel V11 software for patient data mix-up risks and a November 6, 2020 recall of Sentinel V10/V11 models for test comment errors after upgrades. Other recent recalls of similar products include the February 27, 2026 Spacelabs Model 91496 recall for inaccurate cardiac output readings and the March 26, 2026 Spacelabs Ultraview SL Command Module software recall for electrical leakage risk.
How to tell if you have this one
Check for the model number 98700 on the device. Look for serial numbers manufactured between April 2021 and November 2024. The device may have a physical serial number label that doesn't match the programmed serial number.
Brand
Spacelabs
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
U.S.: AR, CA, CO, DE, FL, FA, LA, MA, MI, MN, MT, NC, NE, NU OH, OR, PA, Puerto Rico, TN, TX, UT, VA, WA, and WI. O.U.S.: Argentina Denmark Kuwait Serbia Australia Dominican Republic Lebanon Singapore Austria Ecuador Lithuania Spain Belgium El Salvador Martinique Sweden Benin France Mexico Switzerland Bolivia Germany Netherlands Taiwan Brazil Greece Oman Trinidad and Tobago Brunei Darussalam Guatemala Panama Turkey Canada Honduras Peru United Arab Emirates Chile Hong Kong Poland United Kingdom China Iceland Portugal Columbia India Venezuela Congo Ireland Qatar Viet Nam Costa Rica Israel Republic of Macedonia Croatia Italy Roumanie Czech Republic Korea, Republic of Saudi Arabia
Recall number
Product, codes & lots
Quantity
Z-0684-2025
Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.; Model Number: 98700 UDI-DI code: 10841522128851 Serial Numbers: All serial numbers manufactured between April 2021 to November 2024. Serial Numbers pending.
13,202 devices
Z-0685-2025
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.; Model Number: 98900 UDI-DI code: 10841522128769 Serial Numbers: All serial numbers manufactured between May 2021 to November 2024. Serial Numbers pending.
1,779 devices
Based on the official FDA remedy
What to do — step by step
Check Serial Number Label
Verify the physical serial number label on the device against the serial number programmed into the device.
Where it went and when
Where it was distributed
Distributed in Puerto Rico, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “U.S.: AR, CA, CO, DE, FL, FA, LA, MA, MI, MN, MT, NC, NE, NU OH, OR, PA, Puerto Rico, TN, TX, UT, VA, WA, and WI. O.U.S.: Argentina Denmark Kuwait Serbia Australia Dominican Republic Lebanon Singapore Austria Ecuador Lithuania Spain…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Puerto Rico.
Recall timeline
FDA published this recall 30 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0684-2025 (November 25, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0684-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.