Company: Randox Laboratories, Limited Date of Enforcement Report: 3/11/2020 Class II PRODUCT RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) – Product Usage: A fully automated, random access, clinical chemistry analyzer complete with dedicated analyzer software. For use in clinical laboratories. Recall Number: Z-1349-2020 REASON Software version UI2550642107 for...Read More

Software Glitch over DST Birthdates A news item that reminds us of the importance of software validation, especially in cases where patient records may have birthdates impact by Daylight Savings Time (DST): Paul Eggert commented in The RISKS Digest Volume 32 Issue 16 on a recent issue with delays with hospital lab tests due to software...Read More

Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 3/11/2020 Class II PRODUCT Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower – Product Usage: The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology...Read More

Company: Advanced Bionics, LLC Date of Enforcement Report: 3/11/2020 Class III PRODUCT SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Suite 3.2, CE 0123 – Product Usage: Soundwave 3.2 is used by healthcare professionals to program Advanced Bionics sound processors for use with Advanced Bionics cochlear implants, a device...Read More

Company: Tosoh Bioscience Inc Date of Enforcement Report: 3/11/2020 Class II PRODUCT AIA-360 Automated Immunoassay Analyzer, Product Code 019945 Recall Number: Z-1420-2020 REASON A display screen software issue on the analyzer causes the display to freeze when display screen is touched at the same time as a command from the instrument firmware, causing the instrument...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report: 3/11/2020 Class I PRODUCT CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518) Recall Number: Z-1359-2020 REASON 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping...Read More

Company: Vyaire Medical Date of Enforcement Report: 2/26/2020 Class II PRODUCT Bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation system with an integrated air compressing system. bellavista uses room air and high-pressure oxygen. Air enters through a fresh gas intake port and is compressed together with the oxygen by the...Read More

Company: Normand-Info S.A.S.U. Date of Enforcement Report: 3/11/2020 Class II PRODUCT Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Server 2008 operating systems. Recall Number: Z-1430-2020 REASON A patch was released for a critical remote code execution vulnerability in remote desktop services. This vulnerability can be exploited remotely...Read More