Spacelabs Healthcare recalls Eclipse Mini Model 98900 ECG recorders with potentially mismatched serial numbers due to manufacturing error. Affected units sold from May 2021 to November 2024.
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.
Spacelabs Healthcare is recalling Eclipse Mini Model 98900 ECG recorders because they may have incorrect serial numbers programmed into the device. This mismatch could cause confusion during device identification and potentially lead to improper use or maintenance.
The device may have an incorrect serial number programmed into its software that doesn't match the physical label. This mismatch could cause identification issues during device management or maintenance, but does not pose an immediate safety risk.
Patients using the Eclipse Mini Model 98900 ECG recorder for cardiac monitoring are likely affected. Those with the device serial numbers manufactured between May 2021 and November 2024 are at most risk.
Check for the model number 98900 on the device. Look for serial numbers manufactured between May 2021 and November 2024. The device is a portable ECG recorder used for cardiac monitoring.
Compare the physical serial number on the device with the serial number programmed into the device. If they don't match, the device may be affected.
No, the recall is for potential identification issues due to a serial number mismatch, not an immediate safety hazard.
Check if your Eclipse Mini Model 98900 has a serial number manufactured between May 2021 and November 2024.
No, the device can continue to be used but you should verify the serial number match to ensure proper identification.
We’ve drafted a message you can send Spacelabs Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0685-2025 — Spacelabs Healthcare Spacelabs Healthcare Hello, I own a Spacelabs Healthcare that is covered by recall Z-0685-2025 from Spacelabs Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
