Company: GE Healthcare, LLC Date of Enforcement Report: 6/26/2019 Class II PRODUCT LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Extend Dual DICOM, Model Numbers H41212ZA, H41212RN; b .Vscan Extend Dual USB, Model Number H41212RK; c. Vscan Extend Dual Wi-Fi, Model Numbers H41212YZ, H41212RL; d. Vscan Extend Sector DICOM,...Read More

Company: Monarch Medical Technologies Date of Enforcement Report: 6/26/2019 Class II PRODUCT Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10. Recall Number: Z-1786-2019 REASON Insulin dosing calculations were erroneously high. RECALLING FIRM/MANUFACTURER Monarch Medical Technologies on 5/3/2019. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT...Read More

Company: Arkray Factory USA, Inc. Date of Enforcement Report: 6/26/2019 Class II PRODUCT AUTION HYBRID AU-4050 Recall Number: Z-1850-2019 REASON This correction is being initiated due to a software issue which results in the possibility of incorrect patient information being assigned to sample results when the following rare combination of three specific events were to...Read More

As more “software as a medical device” (SaMD) applications are developed and marketed, there has been an increased focus on what activities and documentation are required for compliance with US medical device regulations and applicable ISO standards.  Along with the rise of SaMD has come the emergence of supporting organizational, management, and production activities that...Read More

May and June 2019 was a busy period for software related recalls – there were 28 recalls as you will see later in the Newsletter. As you plan your software quality assurance activities, we encourage review of published recalls and consider what steps you have in your process to prevent similar problems. Onward toward higher...Read More