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.
Reported: December 25, 2024 Initiated: November 25, 2024 #Z-0685-2025
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.
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.
Details
- Recalling Firm
- Spacelabs Healthcare, Ltd.
- Units Affected
- 1,779 devices
- Distribution
- 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
- Location
- Hertford
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Spacelabs Healthcare, Ltd.. Units affected: 1,779 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 25, 2024. Severity: Moderate. Recall number: Z-0685-2025.
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