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Bp-200 plus blood pressure monitor
Official notice
23 May 2024
Last checked
23 May 2024
An official Health Canada notice concerns Bp-200 plus blood pressure monitor. Masimo identified TC- I reusable tip clip sensors with higher-than-expected variability in SpM2 readings that are outside of the accuracy specification. Masimo's investigation found the TC-I sensors had higher variability with an overall arms of 4.4% compared to the specification of 3.5% arms. These sensors are included with the BP-200 plus device with the SpO2 option. Recall start date: March 14, 2024 Published 2024-05-23.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75550
Official notice
2024-05-23
The hazard
The hazard
Masimo identified TC- I reusable tip clip sensors with higher-than-expected variability in SpM2 readings that are outside of the accuracy specification. Masimo's investigation found the TC-I sensors had higher variability with an overall arms of 4.4% compared to the specification of 3.5% arms. These sensors are included with the BP-200 plus device with the SpO2 option. Recall start date: March 14, 2024
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Affected products
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Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Company & contacts
Company & contacts
Brand: Schiller, Bp-200 Plus Blood Pressure Monitor.
Source & status
Source & status
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Category
Classification
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Recall details
Recall details
Recall number
Classification
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Documents, notices & source
See the official notice and source documents for full details.
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