Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Eclipse PRO REF 98700 The Spacelabs model 98700 is a Recalled by Spacelabs Healthcare, Ltd. Due to Due to a manufacturing error the incorrect 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 PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.
Quantity: 13,202 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
About Spacelabs Healthcare, Ltd.
Spacelabs Healthcare, Ltd. has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report