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Originator: MHRA Medical Device Alerts

Issue date: 30-May-2019 14:00:04

This alert has been issued to:
  • Care Trusts
  • Mental Health Trusts
  • Specialists Trusts
  • NHS Regional Offices
  • Learning Disabilities Trusts
  • Mental Health & Social Care Trusts
  • Ambulance Trusts
  • Mental Health & Learning Disabilities Trusts
  • Acute Trusts
  • Community Trusts

  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • Special Health Authorities

Action category: Action

Title: Aisys and Aisys CS2 anaesthesia devices with Et Control option and software versions 11, 11SP01 and 11SP02 – risk of patient awareness due to inadequate anaesthesia

Broadcast content: Manufactured by GE Healthcare – device may fail to deliver the set agent concentration in End Tidal Control mode.

Additional information: NHS England Regional offices:
Do not cascade to primary care


Alert reference: MDA/2019/022

Action underway deadline: 13-Jun-2019

Action complete deadline: 30-Jul-2019

Attachments:

Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency