BP-200 Plus Blood Pressure Monitor
Brand(s)
Last updated
Summary
Product
BP-200 Plus Blood Pressure Monitor
Issue
Medical devices - Performance
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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