FDAClass IIOctober 10, 2018

Capnostream20 recall

Capnostream20 (INTL) M REFURBISHED, CS78654

Why was Capnostream20 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?

B300001467 B300001028 B300001013 B300001063 B300001239 B300001299 B300001432 B300001465 B300001233 B500001792 B500001690

Product
Capnostream20 (INTL) M REFURBISHED, CS78654
Recalling firm
Oridion Medical 1987 Ltd.
Quantity
11
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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