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Spacelabs Healthcare, Ltd. recalls Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch record
Recalled December 25, 2024 · FDA recall Z-0685-2025 · Spacelabs Healthcare
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. · FDA Class II
Units
1,779 devices
Sold at
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
Description
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
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.
Manufacturer(s)
Spacelabs Healthcare, Ltd.
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →