Covidien Capnostream 35 Portable Respiratory Monitor: False Temperature Alert Causes
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.
Lower-risk 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.
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What happened, in plain English
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. Read more at govinfonow.com/recall/63910-covidien-capnostream-35-portable-respiratory-monitor-false-temperature-alert-causes.
Source Summary by GovInfoNow · govinfonow.com/recall/63910-covidien-capnostream-35-portable-respiratory-monitor-false-temperature-alert-causes · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0515-2021
Cite this page
“Covidien Capnostream 35 Portable Respiratory Monitor: False Temperature Alert Causes.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63910-covidien-capnostream-35-portable-respiratory-monitor-false-temperature-alert-causes. Based on FDA recall #Z-0515-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0515-2021%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Covidien- Category
Medical device
What to do — step by step
Check for Software Update
Download software update V01.05.02.16 (V1.5.2) from the manufacturer's website to fix the false temperature alert issue.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 23 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using my monitor?
No, the recall does not require immediate discontinuation of use. The software update resolves the issue without affecting normal operation.
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Where this comes from
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.
- Official source: FDA Recall #Z-0515-2021 (November 16, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0515-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.