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U.S. Department of Health and Human Services

Class 2 Device Recall Remisol Advance Data Manager

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  Class 2 Device Recall Remisol Advance Data Manager see related information
Date Initiated by Firm August 15, 2019
Create Date March 03, 2020
Recall Status1 Terminated 3 on June 03, 2021
Recall Number Z-1430-2020
Recall Event ID 83687
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Server 2008 operating systems
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Normand-Info S.A.S.U.
7 rue Frederic Degeorge
Arras CEDEX France
Manufacturer Reason
for Recall		 A 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.
FDA Determined
Cause 2		 Other
Action On 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 be found on the following website: https://www.beckmancoulter.com/en/about-beckman-coulter/product-security/product-security-updates. Customers with additional questions were encouraged to contact the firm via email at website: http://www.beckmancoulter.com. The following number was also provided: (800) 526-3821
Quantity in Commerce 6479
Distribution U.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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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