FDA-Device2020-12-09Class II
Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 - Product Usage: use during both no motion and motion conditions and for patients who are well or poorly perfused.
Covidien Llc
Hazard
The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer reports of a false display of the message, "Temperature Exceeds Limits" followed by automatic shutdown of the monitor with no accompanying alarm.
Sold states
Worldwide distribution - US Nationwide distribution.
Affected count
3217
Manufactured in
15 Hampshire St, N/A, Mansfield, MA, United States
Products
Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 - Product Usage: use during both no motion and motion conditions and for patients who are well or poorly perfused.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0515-2021Don't want to check this manually?
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