FDAClass IIOctober 10, 2018

Capnostream20 N W/PRINTER CYVITAL recall

Capnostream20 N W/PRINTER CYVITAL, CS08798

Why was Capnostream20 N W/PRINTER CYVITAL recalled?

The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

B400002649 B400002619 B400002624 B400002632 B400002641

Product
Capnostream20 N W/PRINTER CYVITAL, CS08798
Recalling firm
Oridion Medical 1987 Ltd.
Quantity
5
Distribution
The products were distributed US nationwide and Puerto Rico. The products were distributed to the following foreign countries: 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.
Recall date
October 10, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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