FDAClass IIOctober 10, 2018

Capnostream 20p recall

CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS051COV-03

Why was Capnostream 20p 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?

PM31170001 PM31170002 PM31170003 PM31170004 PM31170005 PM31170006 PM31170007 PM31170008 PM37170009 PM37170010 PM37170011 PM37170012 PM37170013 PM37170014 PM37170015 PM37170016 PM37170017 PM37170018 PM37170019 PM37170020 PM37170021 PM37170022 PM37170023 PM37170024 PM37170025 PM37170026 PM37170027 PM37170028 PM37170029 PM37170030 PM37170031 PM37170032 PM37170033 PM37170034 PM37170035 PM37170036 PM37170037 PM37170038 PM37170039 PM37170040 PM37170041 PM37170042 PM37170043 PM37170044 PM37170045 PM37170046 PM37170047 PM37170048 PM37170049 PM37170050 PM37170051 PM37170052 PM37170053 PM37170054 PM37170055 PM37170056

Product
CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS051COV-03
Recalling firm
Oridion Medical 1987 Ltd.
Quantity
56
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)
Open FDA enforcement record Latest recalls