FDA Medical devices recall ·
Eclipse PRO recall
- Recall number
- Z-0684-2025
- Date
- (initiated November 25, 2024)
- Company / brand
- Spacelabs Healthcare, Inc.
Unit B, Hertford, United Kingdom - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 13,202 devices
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: 98700 UDI-DI code: 10841522128851 Serial Numbers: All serial numbers manufactured between April 2021 to November 2024. Serial Numbers pending.
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
States: Arkansas California Colorado Delaware Florida Louisiana Massachusetts Michigan Minnesota Montana North Carolina Nebraska Ohio Oregon Pennsylvania Puerto Rico Tennessee Texas Utah Virginia Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0684-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.