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.
Other recalls by Spacelabs Healthcare
- Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Product Description: The Spacelab…
FDA Device · Class II · 2026-08-19 · Spacelabs Healthcare - Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product…
FDA Device · Class II · 2026-05-13 · Spacelabs Healthcare - Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Device · Class II · 2026-04-15 · Spacelabs Healthcare - Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology In…
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-0685-2025%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.