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Originator: MHRA Medical Device Alerts

Issue date: 25-Jul-2019 14:00:07

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
  • Ofsted recipients
  • Social Care Providers (registered with CAS)

Action category: Action

Title: Automated external defibrillators: All Telefunken HR1 & FA1 – no valid CE certificate

Broadcast content: Manufactured by Defiteq International BV or GGT Holding BV – the safety and performance of these devices cannot be verified and their safe use can no longer be assured.

Additional information: • Community optometrists
• Community pharmacists
• Dispensing opticians
• General dental practitioners (for information only)
• General practitioners
• Occupational health departments
• Optometrists
• General practice managers
• General practice nurses

This Medical Device Alert is being sent to GPs for information only, in circumstances where patients may seek advice about the contents of this notice. GPs need take no further action on receipt of this alert.


Alert reference: MDA/2019/027

Action underway deadline: 08-Aug-2019

Action complete deadline: 22-Aug-2019

Attachments:

Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency