BD Alaris Gateway Workstation

Issue

BD is issuing a recall because product testing demonstrated that the BD Alaris™ Gateway Workstation can no longer claim protection against fluid ingress according to international standard, ip22/ipx1. Therefore, BD is providing a notice to affected customers to re-enforce the use of the existing directions for use (DFU) and technical service manual (TSM) to minimize potential fluid ingress. During the evaluation of the AGW, the unit was subject to water as per iec 60529 test requirements for ipx2. As part of clause 11.6.5 from iec 60601-1, after the tests of iec 60529, the device is to show no signs of bridging of insulation that is likely to result in the loss of basic safety or essential performance in normal condition or in combination with a single fault condition. The single fault condition identified prior to starting the test was a failure of the pump detection circuit, leading to voltage being on the iec outlet on the tile, when no pump is present. This single fault condition in combination with water being present on the iec c13 outlet, where water could conduct a path from the live terminal to an operator, resulted in ul deeming the test a failure. The DFU contains a claim for ip22 protection. Recall start date: July 7, 2023

What you should do

• Review notice & distribute to users, follow instructions provided, complete/ return response form.