Lower risk Medical device recall · FDA · Published September 16, 2025

Spacelabs Sentinel V11 Software Version 11.6.0: Patient Data Mix-Up Risk

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0416-2026Medical device Spacelabs ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmSpacelabs Healthcare, Ltd.Unit B, Foxholes Centre; John Tate Road · Hertford, United Kingdom

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/51289-spacelabs-sentinel-v11-software-version-11-6-0-patient-data.

Source Summary by GovInfoNow · govinfonow.com/recall/51289-spacelabs-sentinel-v11-software-version-11-6-0-patient-data · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0416-2026

Cite this page

“Spacelabs Sentinel V11 Software Version 11.6.0: Patient Data Mix-Up Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51289-spacelabs-sentinel-v11-software-version-11-6-0-patient-data. Based on FDA recall #Z-0416-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0416-2026%22&limit=1).

The FDA announced on Sept. 16, 2025, that Spacelabs Healthcare is recalling the Sentinel V11 Cardiology Information Management System due to risks of patient data mix-ups. Owners should contact the company for a remedy.

How to tell if you have it

Brand: Spacelabs
Product Name: Sentinel V11
Model/Catalog Number: 92810
Software Version: 11.6.0
UPC: 10841522125751

The hazard

According to the FDA, patient demographic fields may default to those of a previously viewed patient during admission. Additionally, test data intended for one patient may be saved under another's record on systems configured with Resting/Rhythm ECG functionality.

Context

GovInfoNow's records show Spacelabs Healthcare has 4 other recalls on record since 2017-10-11. Other recent recalls of similar products include GE Medical Systems ECG Systems Software Error Risks Patient Data Mix-Up (2026-04-21) and Nova Biomedical StatStrip Glucose Meter System Recall: Patient Data Mix-Up Risk (2026-07-29).

How to tell if you have this one

Check if your Sentinel V11 software version is 11.6.0. The product is used in cardiology information management systems for hospitals and clinics.

Brand
Spacelabs
Product
Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your Sentinel V11 software version is 11.6.0 by checking the product description or software settings.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide - US Nationwide distribution in the state of MN and the countries of CA, DE, FR, GB, IT, NC.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 57 days after the firm started it.

Sep 16, 2025Firm started the recall
Oct 31, 2025FDA classified it Class II
Nov 12, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

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Keep exploring

More Spacelabs recalls

Link to this recall

<a href="https://govinfonow.com/recall/51289-spacelabs-sentinel-v11-software-version-11-6-0-patient-data">Spacelabs Sentinel V11 Software Version 11.6.0: Patient Data Mix-Up Risk (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-0416-2026 (September 16, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0416-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.