Company: Oridion Medical 1987 Ltd.
Date of Enforcement Report 10/10/2018
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,
Recall Numbers: Z-0020-2019…Z-0056-2019
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.
Oridion Medical 1987 Ltd. Jerusalem, Israel on 7/31/2018 Voluntary: Firm Initiated
VOLUME OF PRODUCT IN COMMERCE
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.