Day

May 7, 2020
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...
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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...
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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...
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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...
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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...
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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...
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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...
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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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