Spacelabs recalls model 98700 portable Holter recorders made between April 2021 and November 2024 due to potential mismatch between physical and programmed serial numbers.
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 is recalling portable Holter recorders (model 98700) made from April 2021 to November 2024 because the physical serial number label might not match the serial number programmed into the device. This mismatch could lead to incorrect identification or tracking of the device.
The device may have an incorrect serial number programmed into its software that doesn't match the physical label. This mismatch could cause confusion in device identification or tracking, but does not pose a direct safety risk to users.
Patients using Spacelabs model 98700 Holter recorders purchased between April 2021 and November 2024 are affected. Healthcare providers using these devices for patient monitoring are most at risk.
Check for the model number 98700 on the device. Look for serial numbers manufactured between April 2021 and November 2024. The device may have a physical serial number label that doesn't match the programmed serial number.
Verify the physical serial number label on the device against the serial number programmed into the device.
Due to a manufacturing error, the incorrect device serial number was potentially programmed into the holter recorder, causing the physical serial number label to possibly not match the programmed serial number.
Check if your device's physical serial number matches the programmed serial number. If there's a mismatch, contact Spacelabs for further instructions.
No, the recall is for identification purposes only and does not pose a direct safety risk to users.
We’ve drafted a message you can send Spacelabs to request your refund or repair — edit it as you like.
Subject: Recall Z-0684-2025 — Spacelabs Spacelabs Hello, I own a Spacelabs that is covered by recall Z-0684-2025 from Spacelabs. 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.
