In order to comply with all regulatory requirements and MDR medical device regulation (EU) 2017/745, h/p/cosmos performs regular PMS Post Market Surveillance, updated Clinical Evaluation Reports CER and ongoing Risk Management.
In the latest CER file update 2 additional contra-indications have been found in the evaluation of clinical data and literature and a few recommendations have been made, which are incorporated in this addendum of the original instructions for use.
Please read carefully, distribute to relevant staff and follow all safety information and warnings. Failure to comply may result in death or serious injury. All updated information on safety, Field Safety Notices FSN and FSCA Field Safety Corrective Actions can be found on the manufacturer’s website under https://www.hpcosmos.com/en/safety
Updated manuals / IFU instructions for use can be downloaded: https://www.hpcosmos.com/en/contact-support/media-downloads/manuals