# FDA recall Z-0684-2025

> **Spacelabs Healthcare, Ltd.** · Class II · device recall initiated 2024-11-25.

## 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.

## 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

## Key facts

- **Recall number:** Z-0684-2025
- **Recalling firm:** Spacelabs Healthcare, Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-25
- **Report date:** 2024-12-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hertford, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0684-2025

## Citation

> AI Analytics. FDA recall Z-0684-2025. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0684-2025. Source: US FDA. Licensed CC0.

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