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