Medical Device Data Management Software Affected by Unauthorized Service Credential Access
Service credentials for BD EpiCenter Data Management System were accessed by an unauthorized actor. This creates a risk of unauthorized access to the software and associated data until credentials are updated.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA-regulated medical device with a cybersecurity vulnerability affecting data access and integrity. Although no unauthorized access incidents or patient harm have been reported, the credential compromise represents a risk-of-harm situation qualifying for Score 3 as a risk-of-harm product without reported injury.
Plain-English summary
BD EpiCenter Data Management System (Version 440981) has been recalled due to a cybersecurity vulnerability. According to the manufacturer, product service credentials used by BD technical support teams were accessed by an unauthorized actor. This creates a risk of unauthorized access to the software.
Until these credentials are updated, there is a potential risk of unauthorized access that may impact the confidentiality, integrity, and availability of the software and associated data. BD is recommending that users update their product service credentials.
Approximately 7,974 units of the software have been distributed worldwide, including 2,517 in the United States and 5,457 units internationally. Users should contact BD technical support immediately to obtain updated credentials and implement security measures to prevent unauthorized access to their systems.
The recalled product
- Product
- BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- unauthorized-access
- credential-compromise
- data-integrity-risk
- system-compromise
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Catalog No: 440981
- UDI-DI: 00382904409814
- Serial Numbers: 6GF3TD2
- 2MJHML1
- 697JFF3
- HSB9WV1
- YL00QYF9
- GMWYLN2
- 1TR5JL2
- GD6XCP2
- HGKCXQ2
- FH62RP2
- GDBZCP2
- GD92DP2
- CPQ77X2
- H3JQ3Y2
- 20HJ4Z2
- 5D2BSZ2
- DXMWG13
- DXP1H13
Distribution
Distributed nationwide across the United States.
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