Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.
Enforcement
- Recall Number
- Z-0684-2025
- Event ID
- 95786
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Spacelabs Healthcare, Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 25, 2024
- Initiation Date
- November 25, 2024
- Classification Date
- December 17, 2024
- Address
- Unit B, Foxholes Centre; John Tate Road, Hertford, N/A, United Kingdom
Description
Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.
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.
Model Number: 98700 UDI-DI code: 10841522128851 Serial Numbers: All serial numbers manufactured between April 2021 to November 2024. Serial Numbers pending.
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13,202 devices