Recall Z-0515-2021— Covidien Llc

Name: FDA recall Z-0515-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-16

Class II · Ongoing

Class II FDA medical device recall by Covidien Llc, initiated 2020-11-16. It names one FDA 510(k) clearance: K150272. 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.. 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: Covidien Llc
Classification: Class II
Status: Ongoing
Initiated: 2020-11-16
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K150272 — Capnostream 35 Portable Respiratory MonitorOridion Medical 1987 , Ltd.·cleared 2015-07-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.