Spacelabs Healthcare recalls Sentinel V11 software version 11.6.0 due to potential patient data mix-ups during admission and testing. Affected units may save data for the wrong patient. No remedy specified in recall notice.
Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm ECG functionality, under specific navigation conditions, test data intended for one patient may be saved under another patient's record
Spacelabs Healthcare is recalling Sentinel V11 software version 11.6.0 because it can accidentally save patient test data for the wrong person during admission or testing. This could lead to incorrect medical records if the system is used in a hospital setting.
The software may default to previous patient information during admission, causing new patients to have the wrong details. Additionally, when testing, data for one patient might be saved under another patient's record if the system is configured with Resting/Rhythm ECG functionality.
Healthcare facilities using the Sentinel V11 software version 11.6.0 for cardiology information management are most at risk. Patients and staff at hospitals using this specific software version could potentially see incorrect medical records.
Check if your Sentinel V11 software version is 11.6.0. The product is used in cardiology information management systems for hospitals and clinics.
Verify your Sentinel V11 software version is 11.6.0 by checking the product description or software settings.
The recall is due to two issues: patient demographic fields may default to previous patients during admission, and test data may be saved under the wrong patient's record when using Resting/Rhythm ECG functionality.
The recall notice does not specify any remedy or fix for the software issues.
Check if your Sentinel V11 software version is 11.6.0, as this specific version has the data mix-up issues.
We’ve drafted a message you can send Spacelabs to request your refund or repair — edit it as you like.
Subject: Recall Z-0416-2026 — Spacelabs Spacelabs Hello, I own a Spacelabs that is covered by recall Z-0416-2026 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.
