Recall Z-0684-2025 ยท MWJ Electrocardiograph, Ambulatory (Without Analysis)
Spacelabs Healthcare, Ltd.
Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.
| Date | Dec 17, 2024 (initiated Nov 25, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | On 11/25/2024, the firm sent an "URGENT MEDICAL DEVICE CORRECTION" Letter to customers inform them that the Eclipse Pro and Eclipse MINI cardiac Holter monitors may have mismatched serial numbers between the label and what is programmed in the devices. This is due to a manufacturing error. Customers are instructed to: complete the following steps for each Eclipse device under your control. Following these steps will allow you to check if your device is affected. 1. Visit https://eclipseutils.cardiology.spacelabs.com/ 2. The first time you use this site you will need to register for an accoun |
| Quantity | 13,202 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 Switzerl |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211651 | Eclipse PRO Spacelabs Healthcare, Ltd., Nov 22, 2021 |