Day

April 1, 2020
Company: Intellijoint Surgical, Inc. Date of Enforcement Report: 4/1/2020 Class II PRODUCT Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) – Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, where a reference to...
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Company: Hill-Rom Inc. Date of Enforcement Report: 4/1/2020 Class II PRODUCT NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety (Patient Safety) Software is compatible with the following beds: 1. VersaCare Revision A-J with upgrade kit Revision K with UCB 1.18 2. Centrella (all versions) 3. Progressa (firmware version 1.15.0.0) Recall Number: Z-1554-2020 REASON...
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Company: Insulet Corporation Date of Enforcement Report: 4/1/2020 Class II PRODUCT Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 – M/D: INT1-D001-MG PT-000011 M/D: INT1-D001-MM UDI 10385082000009 The Omnipod DASH Personal Diabetes Manager (PDM) is a mobile, handheld Android device that is intended to communicate with the Omnipod DASH...
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Company: Abbott Gmbh & Co. KG Date of Enforcement Report: 4/1/2020 Class II PRODUCT LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-01) processing module. Recall Number: Z-1580-2020 REASON Abbott has identified potential performance issues for the Alinity ci...
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Company: LivaNova USA Inc Date of Enforcement Report: 4/1/2020 Class II PRODUCT VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators. Recall Number: Z-1563-2020 REASON False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2) Generator programmed to non-0mA output current,...
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Company: QUIDEL CARDIOVASCULAR INC Date of Enforcement Report: 4/6/2020 Class II PRODUCT Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box. Quidel Cardiovascular Inc. 9975 Summers Ridge Road San Diego, CA 92121 USA Quidel.com Recall Number: Z-1552-2020 REASON Due to an error...
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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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