Spacelabs Healthcare recalls Sentinel V10.x and V11.x models 98200/98201 after system upgrades may add incorrect comments to ECG and blood pressure tests, potentially causing confusion in results.
During system upgrade incorrect comments may be added to existing tests. In such instance: Resting ECG and ABP tests which did not contain comments at the time of the upgrade, may have unrelated comments added. Existing comments will not be overwritten or removed. Rhythm ECG Tests may have comments overwritten with unrelated comments. Any tests created after the upgrade are not affected.
Spacelabs Healthcare is recalling Sentinel V10.x and V11.x models 98200 and 98201. These devices may add incorrect comments to existing ECG and blood pressure tests after system upgrades, which could lead to misinterpretation of results.
After system upgrades from version 9 or below to 10 or above, existing ECG and blood pressure tests may receive unrelated comments. Rhythm ECG tests could have comments overwritten. This might cause confusion in interpreting test results, but does not affect tests created after the upgrade.
Healthcare providers using Spacelabs Sentinel V10.x or V11.x models 98200/98201 who have upgraded their systems from version 9 or below to 10 or above. Patients receiving care through these devices may be at risk if test results are misinterpreted.
Check if your device is a Sentinel V10.x or V11.x model with serial numbers 98200 or 98201. You may have been affected if you upgraded from version 9 or below to 10 or above.
Verify your device model and version to see if it matches the recalled Sentinel V10.x or V11.x models 98200 or 98201.
No, tests created after the upgrade are not affected by this issue.
No, existing comments will not be overwritten or removed.
Check if your device is a Sentinel V10.x or V11.x model with serial numbers 98200 or 98201 and if you upgraded from version 9 or below to 10 or above.
We’ve drafted a message you can send Spacelabs Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0563-2021 — Spacelabs Healthcare Spacelabs Healthcare Hello, I own a Spacelabs Healthcare that is covered by recall Z-0563-2021 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.
