Recall Z-0515-2021 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Covidien Llc
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.
| Date | Nov 16, 2020 |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | 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 respirat |
| Quantity | 3217 |
| Distribution | Worldwide distribution - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150272 | Capnostream 35 Portable Respiratory Monitor Oridion Medical 1987 , Ltd., Jul 17, 2015 |