Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0047-2019·Announced 2018-10-10

Oridion Capnostream20 Monitors Recalled for Settings Reset Issue

Oridion Medical is recalling 23 Capnostream20 bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.

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. The defect involves a settings reset that could impact alarm functionality, but the source text does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Oridion Medical 1987 Ltd. is recalling 23 units of the Capnostream20 (INTL) M W/PRINTER bedside patient monitors (model CS08660). The recall was initiated because the date/time, nurse call, and alarm settings on these devices may reset to factory default settings when the monitor is powered off.

The affected products were distributed nationwide in the United States and Puerto Rico, as well as to numerous foreign countries including Argentina, Australia, Canada, and the United Kingdom. The specific serial numbers for the recalled units are listed in the agency's recall record.

Consumers and healthcare facilities should contact Oridion Medical 1987 Ltd. for instructions on how to resolve the issue. The source text does not report any injuries or illnesses associated with this defect.

The recalled product

Product: Capnostream20 (INTL) M W/PRINTER, CS08660
Manufacturer: Oridion Medical 1987 Ltd.
Category: Medical Device — Patient Monitor
Hazard: settings-reset
alarm-failure
Affected units: 23

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 37 recalled by Oridion Medical 1987 Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 37 products in this recall →

Same manufacturer · Oridion Medical 1987 Ltd.

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