Safety communications

This page is for patients, the public and healthcare professionals.

It describes the different communications issued for device safety issues.

How is device safety information communicated?

There are two main types of safety communications:

  1. Field safety notices (FSNs), published by manufacturers.
  2. HPRA safety notices (SNs), published by us.

For more details on these communications, click the menu below. 

Field safety notices

Manufacturers must inform device users if they find a safety issue with their device.

Manufacturers issue FSNs to device users if they find a safety issue.

If your device is affected by a safety issue and you receive a FSN, read it carefully and follow the instructions.

FSNs may have key information or actions, such as:

  • Removal of a device from the market.
  • Updated instructions on how to use a device safely.
  • A patient recall (where patients are to be brought back for re-testing).

We publish a summary of FSNs affecting the Irish market during the first week of each month.

We also publish a list of FSNs circulated to the Irish market where actions remain outstanding.

We can only publish FSNs notified to us.

If you receive an FSN not on our list, please let us know by email at devicesafety@hpra.ie.

 

 

HPRA safety notices

If you receive a FSN from a manufacturer, act on it at once.

Do not wait for a HPRA safety notice . Most FSNs are not accompanied by a HPRA safety notice.

We issue HPRA safety notices to device users when we consider it necessary.

This includes:

  • To give more information to users in Ireland (FSNs often accompany SNs).
  • To raise awareness of a high risk FSN.
  • To raise awareness of an FSN where the manufacturer has not been able to contact all device users.
  • Where a company no longer exists.

More details on our safety notices, including how they are formatted, can be found here.

Anyone can sign up to receive HPRA safety notice by emailing devicesafety@hpra.ie.

What should I do if I receive a HPRA safety notice?

If you are a patient or member of the public, you should:

  • Review the safety notice.
  • Discuss any problems or concerns with your doctor.

If you are a healthcare professional, you should:

  • Ensure the notice reaches the correct person in your organisation.
  • Share the notice with other affected organisations or persons.
  • Review the notice and complete actions as needed.

 



Date Title Type
10/08/2020 Lifepak 500 Automated External Defibrillator. Priority 2 – Warning Warning
05/08/2020 Summary of Field Safety Notices - July 2020 3rd Party Publications
02/07/2020 Summary of Field Safety Notices - June 2020 3rd Party Publications
24/06/2020 Lifeguard LG20, LG50, LG55. Priority 2 - Warning Advisory
17/06/2020 ACTIV.A.C.™ Therapy Units. Priority 2 – Warning Advisory
11/06/2020 Philips HeartStart XL Defibrillator/Monitor. Priority 2 – Warning Warning
11/06/2020 Risk of harmful reactions in laboratories using certain chemicals in combination with bleach. Priority 2 – Warning Warning
08/06/2020 Caution When Purchasing Thermometers Advisory
03/06/2020 Summary of Field Safety Notices - May 2020 3rd Party Publications
05/05/2020 Summary of Field Safety Notices - April 2020 3rd Party Publications
02/04/2020 Summary of Field Safety Notices - March 2020 3rd Party Publications
01/04/2020 MAGEC Spinal Bracing and Distraction System. Priority 2 – Warning Warning
13/03/2020 Potential Cybersecurity Vulnerabilities in Certain Medical Devices with Bluetooth Low Energy Advisory
12/03/2020 T34 Ambulatory Syringe Pumps - Priority 2 – Warning Warning
11/03/2020 Programmable Ventriculo-Peritoneal (PVP) / Programmable Cerebrospinal Fluid (CSF) Shunts. Priority 3 – Advisory Advisory
06/03/2020 Giraffe Omnibed, Giraffe Incubator, Giraffe Omnibed Carestation, Giraffe Incubator Carestation. Priority 2 – Warning Warning
02/03/2020 Summary of Field Safety Notices - February 2020 3rd Party Publications
03/02/2020 Summary of Field Safety Notices – January 2020 3rd Party Publications
07/01/2020 Summary of Field Safety Notices - December 2019 3rd Party Publications
13/12/2019 Cordis S.M.A.R.T. and PRECISE Stents Warning