FDA Device recall 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…
- FDA Device
- Class II
- ongoing
- Published 2024-12-25
On 2024-12-25 the FDA classified a Class II recall of Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record… 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-0685-2025 |
| 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 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.
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: 98900 UDI-DI code: 10841522128769 Serial Numbers: All serial numbers manufactured between May 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.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0685-2025%22
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