BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981
Recall
- Recall Number
- Z-0586-2025
- Event Number
- 95636
- Firm
- Becton Dickinson & Co.
- FEI Number
- 1119779
- Product Code
- JQP
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- October 31, 2024
- Posted
- December 3, 2024
- Address
- 7 Loveton Cir, Sparks, MD, 21152-9212
Description
BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
On October 31, 2024 URGENT" MEDICAL DEVICE PRODUCT CORRECTION letters were sent to consignees. IT, Safety and Security Actions to be Taken: BD encourages customers to follow best practices for maintaining strong security measures to protect hospital networks and medical devices including: "Ensure access to potentially vulnerable devices is limited to authorized personnel "Inform authorized users of issue, and ensure all relevant passwords are tightly controlled "Monitor and log network traffic attempting to reach medical device managementenvironments for suspicious activity "Where possible, isolate affected devices in a secure VLAN or behind firewalls with restrictedaccess that only permits communication with trusted hosts in other networks when needed "Impacted devices do not require use of RDP ports and these should be disabled or blockedif enabled "Ensure permissions on file shares are appropriately established and enforced, and monitorand log access for evidence of suspicious activity "Disconnect devices from the network if connectivity is not necessary Next Steps to be Taken by Customer: 1.Ensure the contents of this notification are read and understood. 2.Share and post this customer letter within your facility network including IT and safety andsecurity department. Forward to any customers to whom you may have distributed theproduct(s) to ensure awareness. 3.Complete the attached Customer Response Form and return it to the BD contact noted on theForm so that BD may acknowledge your receipt of this notification per FDA requirements. 4.Report any adverse health consequences experienced with the use of these products to BD.Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fisher s Lane, Rockville, MD 20852-9787 If you require further assistance, please contact: Technical Service +1 888 451 5514 Technical Questi
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7,974 units (2,517 US, 5,457 OUS)