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...Read More

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...Read More

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...Read More

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...Read More

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,...Read More

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...Read More