Company: Vision RT Ltd Date of Enforcement Report 10/10/2018 Class II: PRODUCT Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only Recall Number: Z-0065-2019 REASON RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB RECALLING FIRM/MANUFACTURER Vision RT Ltd London, United Kingdom on 8/24/2018 Voluntary: Firm Initiated...Read More

Company: Johnson & Johnson Surgical Vision Inc Date of Enforcement Report 10/10/2018 Class II: PRODUCT OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Recall Number: Z-0066-2019 REASON Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specifically, cuts on the plastic hemisphere during DAV do not match the intended cuts shown on...Read More

Company: Johnson & Johnson Surgical Vision Inc. Date of Enforcement Report 10/10/2018 Class lI: PRODUCT OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states “Manufactured for: OptiMedica Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 USA Product Label for Serial Numbers:...Read More

Company: Vision RT LtdDate of Enforcement Report 10/10/2018 Class lI: PRODUCT Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172 Recall Number:...Read More

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,...Read More