June 26, 2019
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
This content is only available to Premium subscribers.  See our Subscribe page for information on subscriptions. 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...
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

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.