Lower riskMedical device recall · FDA · Published November 6, 2020
Spacelabs Sentinel V10/V11 Models 98200 & 98201: Test Comment Errors After Upgrade
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.
Take action
Contact the company
📍Recalling firmSpacelabs Healthcare, Ltd.Unit B, Foxholes Centre; John Tate Road · Hertford, United Kingdom
“Spacelabs Sentinel V10/V11 Models 98200 & 98201: Test Comment Errors After Upgrade.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63979-spacelabs-sentinel-v10-v11-models-98200-98201-test-comment-errors. Based on FDA recall #Z-0563-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0563-2021%22&limit=1).
The FDA announced on November 6, 2020, that Spacelabs Healthcare, Ltd. is recalling Sentinel V10.x and V11.x systems, models 98200 and 98201. The hazard involves incorrect comments being added to or overwritten in existing ECG tests during system upgrades.
How to tell if you have it
Brand: Spacelabs Healthcare
Product: Sentinel V10.x & V11.x
Models: 98200 & 98201
Quantity: 600 units
The hazard
According to the FDA, during a system upgrade, incorrect comments may be added to existing tests. Resting ECG and ABP tests that did not contain comments at the time of the upgrade may have unrelated comments added, while Rhythm ECG Tests may have comments overwritten with unrelated comments.
Context
GovInfoNow's records show Spacelabs Healthcare has issued four other recalls since October 11, 2017. Recent actions include a September 16, 2025 recall for Sentinel V11 Software Version 11.6.0 due to patient data mix-up risks and a November 25, 2024 recall for Eclipse PRO REF 98700 Holter Recorders regarding incorrect serial numbers. Other recent recalls of similar products include the February 27, 2026 Spacelabs Healthcare Multi-parameter Command Module Model 91496 Recall for inaccurate cardiac output readings.
How to tell if you have this one
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.
Brand
Spacelabs Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Version
Verify your device model and version to see if it matches the recalled Sentinel V10.x or V11.x models 98200 or 98201.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 49 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - U.S. Nationwide distribution including in the states of PR, MN, NE, FL, IL, CA, NY, ND, AR, WI, SD, TN, MO, MA, TX, MT, OH, MI, IA, NJ, CT, NC, UT, WV, GA, CO, PA, AL, DC, NV, DE, WA, OR, IN, SC, HI, MS, KS, ID,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 3.9 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0563-2021 (November 6, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0563-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.