Medical device licence · 80960 · Class 2
ALARIS GATEWAY WORKSTATION
No longer licensed: cancelled
Licence status Cancelled; first licensed October 21, 2009; ended December 8, 2025. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 80960
- Licence holder
- Bd Switzerland SarlEysins, Switzerland
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- October 21, 2009
- Ended
- December 8, 2025
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALARIS GATEWAY WORKSTATION CONFIGURATIONS
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “alaris”. A notice may cover another product or only some lots: read it to see what it covers.
- BD Alaris™ Pump Module and subset of Compatible Pump Infusion SetsSeptember 28, 2026 · General hospital and personal use · Performance · Type II
- Alaris & BD Alaris Point-Of-Care Unit (PCU)February 20, 2026 · General hospital and personal use · Device compatibility · Type II
- BD Alaris™ Syringe PumpsFebruary 20, 2026 · General hospital and personal use · Performance · Type II
- BD Alaris™ Pump ModuleOctober 29, 2025 · General hospital and personal use · Performance · Type II
- Alaris™ Pump Module & BD Alaris™ Pump ModuleJuly 22, 2025 · General hospital and personal use · Device compatibility · Type I
- BD Alaris PCUSeptember 11, 2024 · General hospital and personal use · Performance · Type II
- BD Alaris™ EtCO2, PCA, Syringe, and Pump ModulesAugust 30, 2024 · General hospital and personal use · Performance · Type II
- Alaris™ Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite™ Y-site(s)May 3, 2024 · General hospital and personal use · Performance · Type II
- Alaris™ GH Plus Guardrails™ Syringe PumpDecember 20, 2023 · General hospital and personal use · Device compatibility · Type I
- BD Alaris™ Infusion DevicesOctober 30, 2023 · General hospital and personal use · Device compatibility · Type I
- Alaris™ Syringe Pump MK4October 30, 2023 · General hospital and personal use · Device compatibility · Type I
- BD Alaris Gateway WorkstationJuly 21, 2023 · Gastroenterology and urology · Performance · Type II
- BD Alaris Large Volume PumpDecember 1, 2022 · General hospital and personal use · Device compatibility · Type II
- Bd AlarisFebruary 28, 2022 · General hospital and personal use · Unauthorised device · Type II
- BD Alaris Pump Module Model 8100 (2021-03-03)March 18, 2021 · Medical devices · Medical devices · Type II
- Alaris System - PCA & Syringe Pump Module (2020-08-05)August 28, 2020 · Medical devices · Medical devices · Type II
- BD Alaris PC Unit Model 8015 (2020-08-05)August 28, 2020 · Medical devices · Medical devices · Type II
- BD Alaris Pump Module Model 8100 (2020-08-05)August 28, 2020 · Medical devices · Medical devices · Type II
- Alaris System (2020-06-30)July 17, 2020 · Medical devices · Medical devices · Type II
- Alaris System - Server Mobile Systems Manager, PCA Module, Pump & Syringe Pump Module (2020-02-04)February 21, 2020 · Medical devices · Medical devices · Type II
- Important Safety Information on Alaris Infusion Sets and Alaris 8100 Pump Module - Risk of Over-InfusionMay 30, 2019 · Medical devices · New safety information - Medical devices
- Alaris Pump Module, Model 8100 (2019-04-12)May 17, 2019 · Medical devices · Medical devices · Type II
- Asena GH and Alaris Syringe Pumps (2018-06-25)July 5, 2018 · Medical devices · Medical devices · Type II
- Alaris Pump Administration Sets (2018-04-17)May 11, 2018 · Medical devices · Medical devices · Type III
- Alaris Pump Module Model 8100 (2018-04-10)May 4, 2018 · Medical devices · Medical devices · Type II
- Alaris PCA and Syringe Module Models (2017-11-23)December 8, 2017 · Medical devices · Medical devices · Type III
- Alaris Pump Module Model 8100 (2017-06-12)September 26, 2017 · Medical devices · Medical devices · Type II
- Alaris Pump Module Model 8100July 6, 2017 · Medical devices · Medical devices · Type II
- Alaris System PC Unit Model 8015July 6, 2017 · Medical devices · Medical devices · Type II
- Asena GH and Alaris Syringe Pumps (2017-05-04)June 5, 2017 · Medical devices · Medical devices · Type II
- Alaris PK Syringe PumpMarch 10, 2017 · Medical devices · Medical devices · Type II
- Alaris System Model 8100LVPDecember 16, 2016 · Medical devices · Type II
- Alaris System PC Unit Models 8000 and 8015November 18, 2016 · Medical devices · Medical devices · Type II
- ALARIS SYSTEM- SYRINGE PUMP MODULE MODEL 8110 SOFTWARE VERSIONS 9.15 AND 10.5August 12, 2016 · Medical devices · Type III
- Alaris PC Unit Model 8015. Software v9.17 and 9.19 (2016-06-06)June 16, 2016 · Medical devices · Medical devices · Type II
- Alaris System - Alaris Server Mobile (2016-03-03)April 22, 2016 · Medical devices · Medical devices · Type III
- ALARIS SYRINGE PUMPS (2015-10-09)October 9, 2015 · Medical devices · Health products · Type II
- Alaris Syringe Model 8110 (2015-07-09)August 24, 2015 · Medical devices · Health products · Type II
- CareFusion Alaris PC Unit Model 8015 (2015-03-19)May 1, 2015 · Medical devices · Health products · Type III
- Alaris Pump Module Model 8100(2014-04-23)June 5, 2014 · Medical devices · Medical devices · Type I
- Alaris PC Unit Model 8015(2013-06-17)June 5, 2014 · Medical devices · Medical devices · Type II
- Alaris PC Unit Model 8000September 17, 2012 · Medical devices · Type I
- Alaris Pump Module Model 8100 – Intermittent motor stall during infusionSeptember 3, 2012 · Medical devices · Type II
- Alaris Pump Module Model 8100 – Pump Module Door Keypad OverlaySeptember 3, 2012 · Medical devices · Type II
- Alaris PC unit (model 8000) - Total Bolus Display Error - Notice to HospitalsOctober 14, 2010 · Medical devices
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.