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FDA Medical Device Recalls (openFDA)

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

Recall number
Z-1430-2020
Recalling firm
Normand-Info S.A.S.U.
Product
Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Server 2008 operating systems
Status
Terminated
Initiated
2019-08-15
Posted
not on file
Terminated
2021-06-03
Reason
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.
Root cause
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
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
Lot, serial or model codes
All serial numbers
510(k) numbers
not on file
PMA numbers
not on file
Product code
JQP
Firm FEI
3006543086
Firm city
CEDEX
Firm state
not on file
Firm country
France

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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