Oridion Capnostream20 M Adult ICU Monitors Recalled for Settings Reset
Oridion Medical is recalling five Capnostream20 M Adult ICU monitors because date, time, and alarm settings may reset to factory defaults when powered off.
What this means for you
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, and the defect involves settings resetting to factory defaults without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling five units of the Capnostream20 M ADULT ICU (CPM), model CS08654RA, under FDA recall number Z-0045-2019. The recall is due to a defect where the date, time, nurse call, and alarm settings of the bedside patient monitors 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, Austria, Bahrain, Belgium, Canada, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Mexico, Netherlands, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, UAE, UK, and Vietnam. The specific serial codes for the affected units are B3000011359, B300001366, B300001445, B300001452, and B300001460.
Healthcare facilities and consumers should contact Oridion Medical 1987 Ltd. for instructions on how to address the issue. The source text does not specify a particular action such as repair or replacement, nor does it report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Capnostream20 M ADULT ICU (CPM), CS08654RA
- Manufacturer
- Oridion Medical 1987 Ltd.
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- B3000011359 B300001366 B300001445 B300001452 B300001460
Distribution
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.
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