Company: Oridion Medical 1987 Ltd.
Date of Enforcement Report 10/10/2018
Class II:

PRODUCT
Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 – 3.2, Product #: CS08651, CS08651-01, CS08651-01, CS08651-03, CS08657, CS08657-02, CS08657-01, CS08657-03, CS08653, CS08659, CS08750, CS08751, CS78651, CS78653, CS78657, CS78659, CS08652, CS08652-01, CS08652-02, CS08652-03, CS08658, CS08658-01, CS08658-02, CS08658-03, CS08654, CS08654RA, CS08654RN, CS08660, CS08796, CS08798, CS08799, CS78652, CS78654, CS78658, CS78660, CS051COV, CS051COV-03

Recall Numbers: Z-0020-2019…Z-0056-2019

REASON
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.

RECALLING FIRM/MANUFACTURER
Oridion Medical 1987 Ltd. Jerusalem, Israel on 7/31/2018 Voluntary: Firm Initiated

VOLUME OF PRODUCT IN COMMERCE
30,000+

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.

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