Recall Z-0684-2025— Spacelabs Healthcare, Ltd.
Class II · Ongoing
Class II FDA medical device recall by Spacelabs Healthcare, Ltd., initiated 2024-11-25. It names one FDA 510(k) clearance: K211651. Product: Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory 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..
- Recalling firm
- Spacelabs Healthcare, Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-11-25
- Firm location
- Hertford, United Kingdom
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.