Reported Dec 16, 2020 · Terminated
Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is…
Spacelabs Healthcare, Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spacelabs Healthcare, Ltd. · Unit B · Hertford, N/A · N/A
Is this the product you have?
- Sentinel V10.x & V11.x
- Models98200 & 98201 -
- Product Usagedesigned using the latest programming technology and is easy to install and to use
- Lot codes and dates
- Systems that have been upgraded from Version 9 or below to Version 10 or above.
- Amount recalled
- 600
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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