Spacelabs Healthcare, Ltd.: Device Recall
Recall #Z-0685-2025 · 11/25/2024
Recall Details
- Recall Number
- Z-0685-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Spacelabs Healthcare, Ltd.
- Status
- Ongoing
- Date Initiated
- 11/25/2024
- Location
- Hertford, United Kingdom
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,779 devices
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.
Product Description
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.
Distribution Pattern
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
Other Recalls by Spacelabs Healthcare, Ltd.
- Class II: Risk 09/16/2025
- Class II: Risk 11/25/2024