FDAFDA · Food and drugs·Recall number Z-0684-2025
Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.
Published December 25, 2024 · Recall initiated: November 25, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Spacelabs Healthcare, Ltd.
- Distributor
- U.S.: AR, CA, CO, DE, FL, FA, LA, MA, MI, MN, MT, NC, NE, NU OH, OR, PA, Puerto Rico, TN, TX, UT, VA, WA, and WI. O.U.S.: Argentina Denmark Kuwait Serbia Australia Dominican Republic Lebanon Singapore Austria Ecuador Lithuania Spain Belgium El Salvador Martinique Sweden Benin France Mexico Switzerland Bolivia Germany Netherlands Taiwan Brazil Greece Oman Trinidad and Tobago Brunei Darussalam Guatemala Panama Turkey Canada Honduras Peru United Arab Emirates Chile Hong Kong Poland United Kingdom China Iceland Portugal Columbia India Venezuela Congo Ireland Qatar Viet Nam Costa Rica Israel Republic of Macedonia Croatia Italy Roumanie Czech Republic Korea, Republic of Saudi Arabia
- Lot
- Model Number: 98700 UDI-DI code: 10841522128851 Serial Numbers: All serial numbers manufactured between April 2021 to November 2024. Serial Numbers pending.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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