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Eclipse MiniRecalls & reported problems

Spacelabs Healthcare (Washington), Inc · ECLIPSE MINI RECORDER, MULTILINGUAL · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Nov 25, 2024Open, Classified

    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.

    Z-0685-2025 · Root cause: Process control · FDA record ↗

Other Electrocardiograph, ambulatory (without analysis) devices

All Electrocardiograph, ambulatory (without analysis) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.