FDA Device recall Z-0515-2021
Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 - Product Usage: use during both no m…
- FDA Device
- Class II
- ongoing
- Published 2020-12-09
On 2020-12-09 the FDA classified a Class II recall of Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 - Product Usage: use during both no m… by Covidien, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0515-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-11-16 |
| Published | 2020-12-09 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Covidien |
| Distribution | US |
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.
Identifiers
| code_info | Serial numbers: SF16030134 SF16240121 SF16360313 SF16450067 SF17010227 SF17010247 SF17030358 SF17050642 SF17…Serial numbers: SF16030134 SF16240121 SF16360313 SF16450067 SF17010227 SF17010247 SF17030358 SF17050642 SF17090981 SF17110474 SF17120491 SF17140419 SF17150846 SF17180407 SF17200722 SF17240406 SF18020067 SF18020101 SF18020103 SF18030281 SF18090439 SF18090443 SF18110356 SF18271901 SF18271902 SF18271903 SF18271904 SF18271905 SF18271907 SF18271908 SF18271909 SF18271910 SF18271911 SF18271912 SF18271913 SF18271914 SF18271915 SF18271916 SF18271917 SF18271918 SF18271919 SF18271920 SF18271921 SF18271922 SF18271923 SF18271924 SF18271938 SF18271941 SF18280055 SF18301062 SF18420402 SF18430101 SF18430150 SF18430151 SF18430154 SF18430155 SF18430156 SF18430158 SF18430159 SF18430161 SF18430163 SF18430164 SF18430169 SF18430171 SF18430172 SF18430173 SF18430174 SF18430176 SF18430177 SF18430179 SF18430181 SF18430182 SF18430183 SF18430187 SF18430188 SF18430193 SF18430194 SF18430195 SF18430196 SF18430197 SF19250492 SF1926052 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0515-2021%22
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