Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sentinel V10.x & V11.x Recalled by Spacelabs Healthcare, Ltd. Due to During system upgrade incorrect comments may be added...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Spacelabs Healthcare, Ltd. directly.
Affected Products
Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use.
Quantity: 600
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Spacelabs Healthcare, Ltd.
Spacelabs Healthcare, Ltd. has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report