BD (Becton, Dickinson and Company), announced the company will begin remediation for the February 4, 2020 BD Alaris System1 recall through a new version of software.
The February 4, 2020 voluntary recall action notified customers of the following areas where the infusion pump may not operate as expected:
- Software errors related to System Error Code 255-XX-XXX
- Delay options programming
- Low Battery Alarm Failure
- Keep vein open (KVO)/End of Infusion alarms priority
- Use errors related to Customer Concentrations Programming
Under U.S. Food and Drug Administration (FDA) guidance, BD will release Alaris System software version 12.1.2 and associated ancillary software to remediate the affected software.
Effective today, customers can begin scheduling remediation by contacting the BD Recall Support Center at 1-888-562-6018. The new software, which will be available at no cost to customers, is expected to remediate the issues identified in the February 4, 2020 recall notice and provide programming, operational and cybersecurity updates to affected devices; however, this software update has not been reviewed or cleared by the FDA.
