Health product recall

BD Alaris Gateway Workstation

Last updated

Summary

Product
BD Alaris Gateway Workstation
Issue
Medical devices - Performance issue
What to do

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

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
BD Alaris Gateway Workstation All lots. 80203UNS02-30 80203UNS02-34 80203UNS02-54 80203UNS02-74 80203UNS03-34 80203UNS03-52 80203UNS03-53 80300UNS02-53 80300UNS02-72 80203UNS01-32 80203UNS01-53 80203UNS02-50 80203UNS02-72 80203UNS02-73 80300UNS02-32 80203UNS01-235 80203UNS01-72 80203UNS02-235 80203UNS03-30 80203UNS03-32 80300UNS02-235 80203UNS01-34 80203UNS01-50 80203UNS01-92 80203UNS02-33 80203UNS03-54 80300UNS02-34
BD Alaris Gateway Workstation All lots. 80203UNS01-30 80203UNS01-33 80203UNS01-73 80203UNS02-52 80203UNS02-92 80203UNS03-74 80203UNS01-52 80203UNS01-70 80203UNS02-035 80203UNS02-53 80203UNS03-72 80300UNS02-73 80203UNS01-54 80203UNS03-33 80203UNS03-50 80300UNS02-50 80300UNS02-54 80300UNS02-70 80300UNS02-74 80300UNS02-92 80203UNS01-74 80203UNS02-32 80203UNS02-70 80203UNS03-70 80203UNS03-73 80300UNS02-035 80300UNS02-33 80300UNS02-52

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology & Urology
Companies
Bd Switzerland Sarl
Route De Crassier 17, Eysins, Switzerland, 1262
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73969