FDA counted 111 open software defect tickets at BD
A warning letter over quality system violations flagged open tickets for software defects categorized as catastrophic or severe patient harm, plus safety complaints reported late.
BD in MedDevice Cyber coverage: 46 stories, 94 products named, 75 CVEs, and the company's own disclosures.
A warning letter over quality system violations flagged open tickets for software defects categorized as catastrophic or severe patient harm, plus safety complaints reported late.
ICSMA-24-352-01: BD Diagnostic Solutions instruments including BACTEC and Phoenix shipped with default credentials, letting an attacker with network access read, modify or delete data including PHI.
BD's March 29, 2024 bulletin lists 19 products, including Pyxis Medstation and Anesthesia Station systems, as affected by CVE-2024-0353 in ESET real-time file protection on Windows; an update was made available for BD-managed products.
CISA advisory ICSMA-23-331-01 lists seven vulnerabilities, CVE-2023-29060 through CVE-2023-29066 (CVSS v3 up to 5.4), in BD FACSChorus 3.0, 3.1, 5.0 and 5.1 and their HP workstations. BD will address them in an upcoming release and recommends compensating controls.
BD's October 26, 2023 bulletin says BusyBox flaws CVE-2016-2148, CVE-2018-1000517, CVE-2018-20679 and CVE-2019-5747 in the Alaris PC Unit 8015 and FocalPoint Slide Profiler APPS Workstation could expose wireless credentials; PC Unit software 12.3.1 addresses three.
CISA advisory ICSMA-23-194-01 covers eight flaws across the BD Alaris System with Guardrails Suite MX, including an unsigned wireless card firmware package on the PCU Model 8015 (CVE-2023-30559) and a tamperable Guardrails dataset (CVE-2023-30562). BD Alaris System 12.3 fixes some; three PCU flaws remain in 12.3.1.
BD disclosed on April 24, 2023 that a service credential for BD Kiestra TLA, WCA and ReadA with SCU, used only by BD personnel, was temporarily public through a file-analysis service report; BD had it removed and saw no access.
CISA advisory ICSMA-23-047-01 covers CVE-2022-47376 (CWE-257, CVSS v3.1 7.3) in BD Alaris Infusion Central 1.1 through 1.3.2, where a recoverable password left after installation can expose the database. BD is contacting the small group of affected customers to remediate.
CISA advisory ICSMA-22-335-01 covers CVE-2022-43557 (CWE-1299, CVSS 5.3) in BD BodyGuard infusion pumps, including the CME BodyGuard 323 and Twins editions: access through the RS-232 serial port could let someone with physical access configure or disable the pump.
CISA advisory ICSMA-22-277-01 covers CVE-2022-40263 (CWE-798, CVSS 6.6), hard-coded credentials in BD Totalys MultiProcessor 1.70 and earlier that could expose ePHI, PHI and PII. BD scheduled the fix for version 1.71 in Q4 2022.
CISA advisory ICSMA-22-151-01 covers CVE-2022-22767 (CVSS 8.8): BD Pyxis products installed with default credentials, sometimes shared across product types and domain-joined servers, that can give privileged file system access and ePHI. BD is rolling out credential management.
CISA advisory ICSMA-22-151-02 covers CVE-2022-30277 (CWE-613, CVSS 5.7), insufficient session expiration in BD Synapsys 4.20, 4.20 SR1 and 4.30. Version 4.20 SR2 and an upgrade path to 5.10 address it.
CISA advisory ICSMA-22-062-01 covers CVE-2022-22766 (CVSS v3 7.0), BD-managed hard-coded credentials in all versions of 24 BD Pyxis and Rowa products that can lead to the file system and ePHI. BD is strengthening credential management and recommends compensating controls.
CISA advisory ICSMA-22-062-02 covers CVE-2022-22765 (CWE-798, CVSS 8.0), hard-coded credentials in the BD Viper LT system Version 2.0 and later. BD expects the fix in Viper LT Version 4.80 and recommends compensating controls meanwhile.
BD's February 4, 2022 bulletin lists BD Kiestra TLA, WCA and ReadA with SCU, HealthSight Infection Advisor and Clinical Advisor, and BD Insights Research Analytics Dashboards as affected by Log4j CVE-2021-44228 and CVE-2021-45046 in third-party components.
BD's August 16, 2021 bulletin lists BD products in scope for PrintNightmare, the Windows Print Spooler remote code execution flaw CVE-2021-34527, from BACTEC and BD MAX to Pyxis, Rowa and Site~Rite 8; BD reports no exploitation.
BD's July 29, 2021 bulletin lists BD products using Windows 10 and Windows Server 2019 components affected by the Win32k zero-day CVE-2021-1732, including FACS cytometers, Pyxis systems and Kiestra lab automation; BD reports no exploitation.
BD's June 4, 2021 bulletin lists 16 BD products, including Alaris Systems Manager, HealthSight, Kiestra and Pyxis servers, as affected by VMware ESXi, Workstation, Fusion and NSX-T flaws CVE-2020-3992, CVE-2020-3993, CVE-2020-3981, CVE-2020-3982, CVE-2020-3994 and CVE-2020-3995.
BD's December 3, 2020 bulletin lists BD products affected by CVE-2020-16898, the Windows TCP/IP ICMPv6 Router Advertisement flaw known as Bad Neighbor that Microsoft patched October 13, 2020, and says BD is testing the patch.
CISA advisory ICSMA-20-317-01 covers CVE-2020-25165 (CWE-287, CVSS 6.5), a network session authentication flaw between the BD Alaris PC Unit Model 8015 (9.33.1 and prior) and BD Alaris Systems Manager (4.33 and prior). Systems Manager 12.0.1 and later fix the server side. Medigate reported it.
BD's November 6, 2020 bulletin lists BD Knowledge Portals, Intelliport, Kiestra and HealthSight products that use affected Netlogon Remote Protocol versions as in scope for Zerologon, CVE-2020-1472; BD reports no exploitation.
BD's October 30, 2020 Ryuk ransomware bulletin lists BD products in scope for vulnerabilities Ryuk crews exploited against healthcare, including CVE-2017-0144 and CVE-2018-8389; a November 6, 2020 update added Zerologon CVE-2020-1472 and BD Intelliport.
BD's September 28, 2020 bulletin lists BD products on affected Windows versions in scope for CVE-2020-1147, a remote code execution flaw in Microsoft .NET Framework, SharePoint and Visual Studio patched July 14, 2020.
BD's September 8, 2020 bulletin lists Alaris Systems Manager, FocalPoint Large Lab Server, HealthSight, Kiestra and Knowledge Portal products as affected by CVE-2020-1350 in Windows DNS Server and says BD is testing Microsoft's patch.
BD's August 31, 2020 bulletin says VMware vulnerabilities CVE-2020-3957, CVE-2020-3958 and CVE-2020-3959 could affect BD products that use VMware ESXi, including Alaris Systems Manager Server and Pyxis server products.
BD's July 30, 2020 bulletin says the Treck TCP/IP stack vulnerabilities known as Ripple20, CVE-2020-11896 through CVE-2020-11907, could affect third-party components in BD Kiestra TLA, WCA and ReadA with SCU and BD Rowa conveyor technology and label printers.
CISA advisory ICSMA-20-170-06 reports that BD Alaris PC Unit versions 9.13, 9.19, 9.33 and 12.1 carry a vulnerable Linux kernel (CVE-2019-11479, CVSS v3 5.3) that can cause a denial of service and disconnect the unit from the facility wireless network.
BD's June 15, 2020 bulletin lists BD FACS and LSR flow cytometers that use Windows 10 as affected by CVE-2020-0796, a remote code execution flaw in Microsoft SMBv3, and says BD is testing the patch.
BD's April 3, 2020 bulletin lists BD products that use affected Windows components in scope for Microsoft Remote Desktop remote code execution flaws CVE-2020-0609, CVE-2020-0610 and CVE-2020-0611, and says BD is testing Microsoft's patches.
CISA advisory ICSMA-20-091-01 covers CVE-2020-10598 (CVSS v3 6.8), a kiosk mode escape in BD Pyxis MedStation ES and Pyxis Anesthesia (PAS) ES System version 1.6.1 that exposes sensitive data. BD is deploying an update that strengthens kiosk mode.
BD's February 18, 2020 bulletin says it is monitoring Microsoft Win32k vulnerabilities CVE-2019-1458 and CVE-2019-1468, which Microsoft patched; they are not specific to BD products and BD has no reports of exploitation.
BD's January 31, 2020 bulletin says BD products on affected Windows versions are in scope for CVE-2020-0601, a spoofing flaw in Windows CryptoAPI ECC certificate validation; BD reports no exploitation and is testing Microsoft's patch.
BD's December 20, 2019 bulletin lists BD products on workstations running Internet Explorer 9, 10 or 11 in scope for CVE-2019-1367, a flaw that could allow code execution as the current user.
BD's October 30, 2019 bulletin lists BD products running Remote Desktop Services on affected Windows versions in scope for DejaBlue, CVE-2019-1181 and CVE-2019-1182, and recommends Microsoft patches and Network Level Authentication.
CISA advisory ICSMA-19-248-01 covers CVE-2019-13517 (CWE-384, CVSS v3 7.6) in BD Pyxis ES and Pyxis Enterprise Server, where access is not revoked when an Active Directory account expires. BD says the latest software release remediates it.
CISA advisory ICSMA-19-164-01 covers CVE-2019-10959, an unrestricted file upload during firmware update scored CVSS v3 10.0, and CVE-2019-10962, an unauthenticated web interface (CVSS v3 7.3), in BD Alaris Gateway Workstation firmware 1.0.13 through 1.3.1 Build 13. BD issued compensating controls; the product is not sold in the United States.
CISA advisory ICSMA-19-029-02 covers CVE-2019-6517 (CVSS 6.8), improper access control to a privileged account on BD FACSLyric flow cytometry workstations running Windows 10 Pro. BD is disabling the admin account on RUO units and replacing IVD workstations.
CISA advisory ICSMA-18-235-01 covers CVE-2018-14786 (CVSS v3 9.4), missing authentication in BD Alaris Plus CC, GH, GS and TIVA syringe pumps at version 2.3.6 and earlier when the serial port is connected to a terminal server. BD says the attack fails when the pump sits in an Alaris Gateway Workstation dock.
CISA advisory ICSMA-18-142-01 covers CVE-2018-10593 and CVE-2018-10595 (CVSS v3 5.6 and 6.3) in BD Kiestra TLA, WCA and InoqulA+ software: DB Manager 3.0.1.0, PerformA 3.0.0.0 and earlier, and ReadA Overview 1.1.0.2 and earlier. BD is deploying a mitigation remotely or on premise.
CISA advisory ICSMA-18-114-01 lists 12 BD Pyxis products, all versions, as affected by the KRACK WPA2 key reinstallation flaws (CVE-2017-13077, CVSS 6.8). BD is deploying third-party vendor patches through its routine process and contacting users whose devices need coordination.
BD's January 5, 2018 bulletin lists BD products in scope for the Meltdown and Spectre processor flaws, from FACS cytometers to Pyxis and Rowa, rates the risk low-impact, and recommends patching and firmware updates.
BD's October 27, 2017 bulletin lists Alaris PC Units 8000 and 8015, the Alaris Gateway Workstation and Pyxis stations as in scope for the WPA2 KRACK vulnerabilities; some were patched and others need customer coordination.
BD's May 16, 2017 bulletin says SMB1, default third-party database credentials and hardcoded application passwords in BD Kiestra database 3.0.61 and earlier could let an attacker reach the Kiestra database and limited PHI and PII.
CISA advisory ICSMA-17-082-01 reports a hard-coded password (CVE-2017-6022, CVSS v3 7.3) in BD Kiestra PerformA 2.0.14.0 and earlier and KLA Journal Service 1.0.51 and earlier. BD scheduled remote updates between April and October 2017.
CISA advisory ICSMA-17-017-01 reports that all versions of the BD Alaris 8000 PC unit keep wireless network authentication credentials unencrypted on internal flash memory (CVE-2016-8375, CVSS v3 4.9). BD published a security bulletin for the Alaris PC unit model 8000.
CISA advisory ICSMA-17-017-02 covers two physical-access flaws (CVE-2016-8375, CVE-2016-9355) in the BD Alaris 8015 PC unit that expose wireless network credentials and allow writes to device memory. BD has no product fix and points users to compensating controls.
BD products with the device attributes their own public documentation states, and the advisories in our coverage that share those attributes.
| Product | Device type | Attributes | Matched advisories |
|---|---|---|---|
| BD Alaris Infusion System with Guardrails Suite MX | Pump, Infusion | 20 | 38 |
| BD Phoenix Automated Microbiology System | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | 15 | 24 |
| BD Alaris System with Guardrails Suite MX v12.1.2 | Pump, Infusion | 23 | 14 |
| BD Vaginal Panel | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System | 5 | 4 |
| EnCor EnCompass Breast Biopsy and Tissue Removal System | Instrument, Biopsy | 15 | 3 |
| WavelinQ Generator | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 1 |
| AccuCath Ace Intravascular Catheter | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 0 |
| Bard Temporary Pacing Electrode Catheter Needle / Cannula | Electrode, Pacemaker, Temporary | 1 | 0 |
| BD Alaris Pump Infusion Set | Set, Administration, Intravascular | 3 | 0 |
| BD Cathena (TM) Safety IV Catheter | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 0 |
| BD Cathena Safety IV Catheter | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 0 |
| BD Enteric Bacterial Panel for BD COR System | Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System | 2 | 0 |
| BD FACSLyric Flow Cytometer | Flow Cytometric Reagents And Accessories. | 5 | 0 |
| BD Intima II Closed IV Catheter System | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 0 |
| BD Intraosseous Infusion System | Needle, Interosseous | 4 | 0 |
| BD Intraosseous Vascular Access System EMS Powered Driver | Needle, Interosseous | 3 | 0 |
| BD Kiestra IdentifA | Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry | 16 | 0 |
| BD Kiestra IdentifA | Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry | 6 | 0 |
| BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) | Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms | 3 | 0 |
| BD MAX Enteric Bacterial Panel | Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System | 3 | 0 |
| BD MAX Enteric Parasite Panel | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 2 | 0 |
| BD MAX Enteric Viral Panel | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 2 | 0 |
| BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System | 4 | 0 |
| BD Nexiva Closed IV Catheter System | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 0 |
| BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 0 |
| BD PowerPiCC Catheter | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 1 | 0 |
| BD Veritor System for SARS-CoV-2 | Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings | 6 | 0 |
| CentroVena Central Venous Catheter (CVC) with the CentroVena One | Central Venous Catheter With Manual Insertion System | 1 | 0 |
| Crosser iQ CTO Recanalization System | Catheter For Crossing Total Occlusions | 6 | 0 |
| ELEVATIONTM Breast Biopsy System | 4 | 0 | |
| Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser | Powered Laser Surgical Instrument | 8 | 0 |
| Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French | Tubes, Gastrointestinal (And Accessories) | 3 | 0 |
| PowerPort ClearVUE Slim ECG Enabled Implantable Port | Port & Catheter, Implanted, Subcutaneous, Intravascular | 2 | 0 |
| Rotarex Atherectomy System | 2 | 0 | |
| Semi-Floating Temporary Pacing Electrode Catheter | Electrode, Pacemaker, Temporary | 2 | 0 |
| Vaccess CT Low-Profile Power-Injectable Implantable Port | Port & Catheter, Implanted, Subcutaneous, Intravascular | 1 | 0 |