Company: Elekta Inc Date of Enforcement Report: 5/7/2020 Class II PRODUCT Elekta MONACO RTP Sytem, radiation treatment planning software system – Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. Recall Number: Z-1803-2020 REASON The Monaco RTP Radiation Treatment Planning System may change the...Read More

Company: Viewray, Inc. Date of Enforcement Report: 5/7/2020 Class II PRODUCT ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software Recall Number: Z-1803-2020 REASON Registering dose and structures in the treatment delivery workflow could result in an alignment discrepancy between the imported previously delivered...Read More

Company: Philips North America, LLC Date of Enforcement Report: 5/7/2020 Class II PRODUCT Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluoroscopic x-ray system System code: 722079 Recall Number: Z-1809-2020 REASON When a user acquires XperCT scan on an Azurion 2.0 system, enters the...Read More

Company: ICU Medical, Inc. Date of Enforcement Report: 5/7/2020 Class II PRODUCT ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499 Recall Number: Z-1835-2020 REASON Firm identified several software issues through internal testing of its Cogent Hemodynamic Monitoring System. These issues may result in inaccurate monitoring data, unit shutdown, and/or loss of...Read More

Company: Boston Scientific Corporation Date of Enforcement Report: 5/7/2020 Class II PRODUCT iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System Recall Number: Z-1804-2020 REASON Certain iLab Polaris Systems which were upgraded with a previous 2.10 software version (disk batch 629774) contained a bug in which only the True Color Secondary Capture (SC) format will...Read More

Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 5/7/2020 Class II PRODUCT Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower Recall Number: Z-1797-2020 REASON Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on...Read More

Company: Obalon Therapeutics Inc Date of Enforcement Report: 5/7/2020 Class II PRODUCT Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 – Product Usage: The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed 6 months after the...Read More