ClearanceBrief
Recall Z-1430-2020 ยท JQP Calculator/Data Processing Module, For Clinical Use

Normand-Info S.A.S.U.

Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Server 2008 operating systems

DateAug 15, 2019
StatusTerminated
ReasonA patch was released for a critical remote code execution vulnerability in remote desktop services. This vulnerability can be exploited remotely without authentication on certain operating systems. An attacker who successfully exploited this vulnerability could execute arbitrary code on the target system; then install programs; view, change, or delete data; or create new accounts with full user rights. If the vulnerability could be exploited locally, it would lock down the computer.
Root causeOther
ActionOn 08/15/19, Urgent Medical Device Recall notices, dated 08/09/19, were mailed to customers informing them to follow the instructions in the notice to download the patch for their system(s). In addition, customers were asked to share this information with laboratory staff, to retain the notification as part of their laboratory Quality System documentation, and to complete and return the response form. If you are a centralized license holder, please provide the other affected laboratories of your organization or association with a copy of this letter. The latest information on cybersecurity can
Quantity6479
DistributionU.S.: NY, AZ, FL, NJ, MA, OH, CA, IL, NC, OK, IN, KY, OR, MI, WI, PA, UT, GA, VA, TX, NE, SD, IA, MN, MD, DE, SC, MT, WV, LA, MO, TN, NM, NV, HI, WA, WY, AL, AR, MS, RI, ID, ME, DC, ND, AK, CO, CT, KS, NH, VT
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.