Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 the patient s electrocardiogram.

U.S. FDA — Device Enforcement · United Kingdom · 2024-11-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0685-2025
Date of alert
2024-11-25
Country / jurisdiction
United Kingdom
Risk level
Class II
Risk type
recall
Brand
Spacelabs Healthcare, Ltd.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10841522128769
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.