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Type of Product	Medical Device
TGA Recall Reference	RC-2020-RN-00153-1
Product Name/Description	BD Alaris Systems BD Alaris System PC Unit Model 8000, software versions 9.5 and prior BD Alaris System PC Unit Model 8015, software versions 9.33 and prior BD Alaris Pump Module Model 8100, software versions 9.33 and prior Alaris Syringe Module Model 8110, software versions 9.33 and prior Alaris PCA Module Model 8120, software versions 9.33 and prior ARTG 146664 & 175353
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	19/02/2020
Responsible Entity	Becton Dickinson Pty Ltd
Reason/Issue	Becton Dickinson (BD) has identified 5 software issues with BD Alaris Systems: Issue 1: Software errors related to System Error Code 255-XX-XXX Issue 2: Delay Options programming Issue 3: Low Battery Alarm Failure Issue 4: Keep Vein Open (KVO) / End of Infusion alarms priority Issue 5: Use Errors related to Custom Concentration programming One report of death has been received worldwide in relation to issue 5 above.
Recall Action	Product Defect Correction
Recall Action Instructions	BD is advising these issues will be corrected in an upcoming software release. Customers are advised to refer to the Customer Letter supplied to impacted facilities to prevent these from occurring in the interim. This action has been reviewed and is considered complete in accordance with the requirements of the URPTG
Contact Information	02 8875 7000 - BD