Company: Covidien Llc
Date of Enforcement Report: 12/9/2020
Class II
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.
Recall Number: Z-0515-2021
REASON
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.
RECALLING FIRM/MANUFACTURER
Covidien LLC on 11/16/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
3217
DISTRIBUTION
U.S. Nationwide and International