Jerusalem/Needham – January 19, 2012 – Oridion Systems Ltd. (SIX Swiss Exchange: ORIDN), announced today that the United States Food and Drug Administration (FDA) has advised the company that the import alert issued on all of Oridion’s medical devices has been significantly narrowed.

The scope of the import alert now only applies to infant neonatal intubated CO2 sampling lines. While the infant neonatal CO2 sampling lines remain on import alert and will not be commercially available in the United States until further notice, the company has immediately resumed shipments of all other products including CO2 sampling lines, modules and patient monitors.

FDA issued the import alert in December, 2011 in part, due to concerns that particulate matter may be found in the single-unit packaged CO2 sampling lines. The source of the particulates originates from the paper insert, warning label and banding tape inside the package. In rare cases involving airway adapters only, particulate may be located inside the airway adapter and may potentially enter a patient’s respiratory system.

The company has had no reports of any adverse incidents relating to the presence of particulate and Oridion has not identified any evidence of a serious health risk from the particulates. Oridion continues to work with FDA to assure that this issue is thoroughly resolved and is fully committed to addressing all FDA concerns for ensuring that its products consistently meet all quality and regulatory requirements. Oridion is sending a letter to clinicians to advise them of certain precautionary steps.