Spacelabs Healthcare, Ltd.: Medical Device Recall in 2024 - (Recall #: Z-0685-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 25, 2024

Date Posted: December 25, 2024

Recall Number: Z-0685-2025

Event ID: 95786

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.

Status: Ongoing

Product Quantity: 1,779 devices

Code Information:

Model Number: 98900 UDI-DI code: 10841522128769 Serial Numbers: All serial numbers manufactured between May 2021 to November 2024. Serial Numbers pending.

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

Voluntary or Mandated:

Voluntary: Firm initiated