Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 4/28/2021 Class II PRODUCT Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis High-End Servers- 10910620 Sensis Vibe Hemo- 11007641 Sensis Vibe Combo- 11007642 Sensis Vibe is a recording...Read More

Company: Welch Allyn Inc Mortara Date of Enforcement Report: 4/28/2021 Class II PRODUCT ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 – Product Usage: indicated for use on adult and pediatric populations. Recall Number: Z-1482-2021 REASON Devices do not meet IEC 60601-2-27 requirements as labeled. RECALLING...Read More