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Covidien Llc recalls Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 - Product Usage:
Recalled December 9, 2020 · FDA recall Z-0515-2021 · Covidien
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. · FDA Class II
Units
3217
Sold at
Worldwide distribution - US Nationwide distribution.
Description
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.
Product
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.
Manufacturer(s)
Covidien Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →