Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable… — Class II medical device recall Z-0684-2025
Ongoing recall by Spacelabs Healthcare, Ltd., reported 2024-12-25, distributed in AR, CA, CO, DE, FL, LA, MA, MI…. Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter rec
| Recall number | Z-0684-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spacelabs Healthcare, Ltd., Hertford, United Kingdom |
| Recall initiated | 2024-11-25 |
| Classified | 2024-12-17 |
| Reported by FDA | 2024-12-25 |
| Distributed | AR, CA, CO, DE, FL, LA, MA, MI, MN, MT, NC, NE, OH, OR, PA, PR, TN, TX, UT, VA, WA, WI |
| Countries outside the US | AE, AR, AT, AU, BE, BO, BR, CA, CH, CL, CN, CR, CZ, DE, DK, DO, EC, ES, FR, GB, GR, GT, HK, HN, HR, IE, IL, IN, IS, IT, KR, KW, LB, LT, MX, NL, OM, PA, PE, PL, PT, QA, RS, SA, SE, SG, SV, TR, TT, TW, VE, VN |
| Quantity | 13,202 devices |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10841522128851 |
| Model numbers | 98700 |
Product
Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0684-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.