Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is Recalled by Spacelabs Healthcare, Ltd. Due to Due to a manufacturing error the incorrect device...

Date: November 25, 2024
Company: Spacelabs Healthcare, Ltd.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Spacelabs Healthcare, Ltd. directly.

Affected Products

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.

Quantity: 1,779 devices

Why Was This 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.

Where Was This Sold?

This product was distributed to 21 states: AR, CA, CO, DE, FL, LA, MA, MI, MN, MT, NE, NC, OH, OR, PA, TN, TX, UT, VA, WA, WI

Affected (21 states)Not affected

About Spacelabs Healthcare, Ltd.

Spacelabs Healthcare, Ltd. has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report