Oridion Systems Ltd : FDA Import Alert

News Release

Jerusalem/Needham MA - December 27, 2011 - Oridion Systems Ltd. (SIX Swiss Exchange: ORIDN), announced today that it learned that the United States Food and Drug Administration ("FDA") has imposed an import alert on all Oridion medical devices, preventing their importation into the United States of America. The FDA decision follows an FDA inspection of Oridion that was carried out in June 2011 and a warning letter that the Company received and responded to in October 2011.
As the FDA's observations focused on purchasing controls, Oridion has initiated steps necessary to correct these issues. Oridion is in contact with the FDA to understand the issues that led to this alert. The Company will publish an update as and when clarifying information becomes available.
The import alert is affecting Oridion's ability to sell its medical devices into the USA in the remaining days of the fourth quarter, 2011. Accordingly, Oridion expects that growth for the fourth quarter relative to the same period last year will be minimal. The Company expects that overall revenue growth for the full year will be approximately 17%, and will fall short of the
20% guidance solely as a consequence of this inability to supply its medical devices into the US market. The effect on sales in 2012 is too early to be determined. Nevertheless, based on management's plan of corrective actions, Oridion believes that the disruptions to product supply into the US should not go beyond the first half of 2012. Sales to the remainder of the world should not be affected by the FDA decision.
"Oridion is handling this as it handles all FDA matters, and that is with the highest priority. We are confident in the safety and effectiveness of our products and are taking all the steps necessary to ensure that our quality assurance processes are fully in compliance with FDA requirements. We are working with the FDA to end this situation as soon as possible," said Alan Adler, Chairman and Chief Executive Officer.

For further information please contact

Walter Tabachnik, Chief Financial Officer

e-mail [e-mail] website http://www.oridion.com phone [phone]

address Oridion Systems Ltd., P.O. Box 45025, 91450 Jerusalem, Israel

About Oridion

Oridion Systems Ltd. (www.oridion.com) is a global medical device company specializing in patient safety monitoring. The Company operates through wholly owned subsidiaries in Israel and

the United States.

Oridion develops proprietary medical devices and patient interfaces, based on its patented Microstream® technologies, for the enhancement of patient safety through the monitoring of the carbon dioxide (CO2) in a patient's breath. These products provide effective, proven airway management and are used in various clinical environments, including procedural sedation, pain management, critical care units, post-anesthesia care units, emergency medical services, transport, alternate care and other settings where patients' ventilation may be compromised and at risk.

Certain statements made herein that are not historical are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. The words "estimate" "project" "intend" "expect" "believe" and similar expressions are intended to identify forward-looking statements. These forward- looking statements involve known and unknown risks and uncertainties. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, among others, our ability to maintain profits, the market demands for our Capnography products, our ability to focus our team on the Capnography business, changes in general economic and business conditions, inability to maintain market acceptance to the Company's products, inability to timely develop and introduce new technologies, products and applications, rapid changes in the market for the Company's products, loss of market share and pressure on prices resulting from competition, introduction of competing products by other companies, inability to manage growth and expansion, loss of key OEM partners, inability to attract and retain qualified personnel, inability to protect the Company's proprietary technology.

Furthermore, this press release does not constitute an offer to sell or a solicitation of an offer to buy any securities. The Company's shares issued have not been, and will not be, registered under the US Securities Act of 1933, as amended (the "Securities Act"), or under any of the relevant Securities Laws of any state of the United States. The Company's shares may not be offered, sold or delivered, directly or indirectly, to, or for, the account of any US person (as defined in regulation S under the Securities Act) in or into the United States, or by use of the US mail, or by any means or instrumentality of United States interstate commerce, absent registration, or an exemption from registration under the Securities Act.

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