Day

July 15, 2020
Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Date of Enforcement Report: 7/15/2020 Class II PRODUCT CareLink SmartSync Device Manager, Model Number 24970A Recall Number: Z-2505-2020 REASON There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features...
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Company: Vitalconnect Inc. Date of Enforcement Report: 7/15/2020 Class II PRODUCT A software graphical user interface intended for use by healthcare professionals to display physiological data collected by the wireless remote monitoring system in healthcare settings. This is a secondary, adjunct patient monitor and is not intended to replace existing standard-of-care patient monitoring. Recall Number:...
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Company: Ra Medical Systems, Inc. Date of Enforcement Report: 7/15/2020 Class II PRODUCT DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and delivery system, collectively the DABRA Laser System”. The system is designed to deliver the energy to the surgical site to ablate unwanted material....
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Company: Radiometer Medical ApS Date of Enforcement Report: 7/15/2020 Class II PRODUCT Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the following configurations: ABL835, ABL830, ABL827, ABL825, ABL825, ABL820, ABL817, ABL815, ABL810, ABL805 and ABL810 BG only and ABL800Basic. The FlexQ module...
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Company: Capso Vision, Inc. Date of Enforcement Report: 7/15/2020 Class II PRODUCT The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795 – Product Usage: intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small...
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Company: Tomtec Imaging Systems Gmbh Date of Enforcement Report: 7/15/2020 Class II PRODUCT TOMTEC-ARENA TTA2 (sw version no. 2.20 and lower) Picture archiving and communications system. Recall Number: Z-2496-2020 REASON The firm discovered a software issue associated with the Image-Com module/clinical application package (CAP) interface for 3D application in the ARENA software, where measurements from...
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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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