Oridion Systems Ltd : FDA letter

News Release

Jerusalem/Needham MA – October 12, 2011 – Oridion Systems Ltd. (SIX Swiss Exchange: ORIDN), announced today that it has received a warning letter from the United States Food and Drug Administration (“FDA”) relating primarily to procedures to ensure that all purchased or received product conforms to specified requirements. FDA’s observations focused on purchasing controls of Oridion’s contract manufacturers.

The warning letter is the direct consequence of an FDA inspection of Oridion carried out in June 2011 subsequent to the limited recall of a very small part of Oridion’s consumables products that was announced in May 2011.

At the conclusion of the FDA inspection, the company assembled a team, including its internal quality and regulatory associates as well as outside experts, to initiate and implement corrective actions. A formal response will be submitted to the FDA as is required under the letter.

“Oridion wants to assure customers, users and the general public that we stand fully behind the safety and quality of our products. We take all FDA matters very seriously and we are in the process of fully addressing the FDA’s concerns,” said Alan Adler, Chairman and Chief Executive Officer.

For further information please contact

Alan Adler, Chairman and Chief Executive Officer

Walter Tabachnik, Chief Financial Officer

Elena Gerberg, Investor Relations

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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