medical Class II Updated 2020-12-16

Spacelabs Healthcare, Ltd. recalls Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usag

Recalled Product

Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Systems that have been upgraded from Version 9 or below to Version 10 or above.
View official government recall

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