Health product recall

BP-200 Plus Blood Pressure Monitor

Brand(s)
Last updated

Summary

Product
BP-200 Plus Blood Pressure Monitor
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

BP-200 Plus Blood Pressure Monitor

More than 10 numbers, contact manufacturer.

5.310011

Issue

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

Schiller AG

Altgasse 68, Baar, Zug, Switzerland, 6341

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75550

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