Covidien recalls Capnostream 35 Portable Respiratory Monitors with serial numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02. Software update V01.05.02.16 (V1.5.2) addresses false temperature alerts that trigger automatic shutdown without alarm.
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.
Covidien is recalling certain Capnostream 35 Portable Respiratory Monitors due to software issues that cause false temperature alerts, leading to automatic shutdowns without warning. This could disrupt patient monitoring during critical care situations.
The software error causes the monitor to display a false 'Temperature Exceeds Limits' message, then automatically shuts down without sounding an alarm. This could interrupt critical patient monitoring if the device is used during motion or for patients with unstable perfusion.
Users of the Capnostream 35 monitors with specific serial numbers listed in the recall. Healthcare providers and patients using these devices during medical care are most at risk.
Check your Capnostream 35 monitor's serial number against the list provided in the recall. The affected units have serial numbers starting with SF (e.g., SF16030134) or specific product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02.
Download software update V01.05.02.16 (V1.5.2) from the manufacturer's website to fix the false temperature alert issue.
Covidien released software update V01.05.02.16 (V1.5.2) after customer reports of false temperature alerts causing automatic shutdowns without alarms.
No, the recall does not require immediate discontinuation of use. The software update resolves the issue without affecting normal operation.
Check your serial number against the list of affected units provided in the recall notice.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-0515-2021 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-0515-2021 from Covidien. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
