Capnostream 35 Portable Respiratory Monitor Recalled for False Temperature Display
Covidien LLC is recalling 3,217 Capnostream 35 Portable Respiratory Monitors because they may display a false 'Temperature Exceeds Limits' message and shut down without an alarm.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific hazard is a false alarm and shutdown, which is a functional defect rather than a direct physical injury risk, aligning with a Moderate severity rating.
Plain-English summary
Covidien LLC is recalling 3,217 units of the Capnostream 35 Portable Respiratory Monitor, including product numbers PM35MN02, PM35MN01, PM35MN05, and DLPM35MN02. The affected devices were distributed worldwide and nationwide in the United States.
The recall was initiated in response to customer reports that the monitors displayed a false 'Temperature Exceeds Limits' message followed by an automatic shutdown without an accompanying alarm. This malfunction could potentially affect patient monitoring during both motion and no-motion conditions, as well as for patients who are well or poorly perfused.
The firm has released software update V01.05.02.16 (also known as V1.5.2) to address the issue. Users should check their device serial numbers against the list provided in the official recall notice and contact the manufacturer for instructions on applying the software update.
The recalled product
- 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.
- Manufacturer
- Covidien Llc
- Affected units
- 3,217
Distribution
Distributed nationwide across the United States.
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