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.

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.

On November 16, 2020, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed of the software issue affecting devices. Medtronic has developed a software update which includes a fix for this issue, available at http://medtronic.com/cap35software. Medtronic has also issued an addendum to the Capnostream35 Portable Respiratory Operator's Manual which can be accessed at manuals.medtronic.com. Customers are to take the following actions: - Share the notification of the recall with all care environments where the Capnostream35 portable respiratory monitors are used. If your facility has distributed these portable respiratory monitors to other persons or facilities, please promptly forward a copy of this letter to those recipients. -Access and download software version V1.5.2 from the Medtronic website via the following link which includes directions on how to download and install the software on all devices at your facility. http://medtronic.com/cap35software -Return the completed Acknowledgement and Receipt Form by fax or email even if you have no inventory. If you are aware of any incidents related to this issue or if you have any questions, please contact our Technical Service Department at 800.255.6774, option 1, or [email protected] to provide information regarding those events so regulatory reporting obligations can be fulfilled.