FDA Device recall 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 elec…
- FDA Device
- Class II
- ongoing
- Published 2024-12-25
On 2024-12-25 the FDA classified a Class II recall of Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory elec… by Spacelabs Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0684-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-25 |
| Published | 2024-12-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Spacelabs Healthcare |
| Distribution | AR, CA, CO, DE, FL, LA, MA, MI, MN, MT, NC, NE, OH, OR, PA, PR, TN, TX, UT, VA, WA, WI |
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
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.
Identifiers
| code_info | Model Number: 98700 UDI-DI code: 10841522128851 Serial Numbers: All serial numbers manufactured between April 2021 to November 2024. Serial Numbers pending. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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FDA Device · Class II · 2025-11-12 · Spacelabs Healthcare - Brand Name: Branding is not applied to this product
FDA Device · Class II · 2025-10-22 · Spacelabs Healthcare
All Spacelabs Healthcare recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0684-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.