Safety Notices

HPRA Safety Notice Communication

We publish notices relating to the safety and/or quality of medical devices. The issues covered by these notices will range from quality defect information to product recalls, to updated information on the appropriate usage of the medical devices.

View the current safety notices for medical devices below.

If you would like to receive copies of these notices at the time of publication via e-mail please forward an e-mail request to devicesafety@hpra.ie.

Learn more about HPRA safety notices.

Manufacturer's Field Safety Notices

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market.

The HPRA puts these notices on our website for information.

Learn more about field safety notices.

Field Safety Notices - Outstanding Actions

When a field safety notice is issued by a medical device manufacturer on the Irish market, the HPRA seek confirmation from the manufacturer that the required action has been completed. Sometimes, completion of the action is delayed or hampered due to issues experienced by the manufacturer. The HPRA publishes details of field safety notices that have been circulated to the Irish market for which action remains outstanding.

Learn more about field safety notices.

Date Title Type
30/01/2015 HeartStart MRx Monitor/Defibrillator Priority 2 – Warning Warning
07/01/2015 Summary of Field Safety Notices - December 2014 3rd Party Publications
19/12/2014 Autopen Classic, Autopen 24, Densupen, Autopen 3ml for Teriparatide. Priority 2 – Warning Warning
17/12/2014 HeartStart MRx Monitor/Defibrillator / Philips M1783A and M5526A Sync Cables - Priority 2 – Warning Warning
15/12/2014 Juvéderm ULTRA 4 Priority 2 – Warning Warning
02/12/2014 Summary of Field Safety Notices - November 2014 3rd Party Publications
26/11/2014 Samaritan PAD 300 / PAD 300P Public Access Defibrillators. Priority 2 – Warning Warning
26/11/2014 RENASYS™ ® range of Negative Pressure Wound Therapy (NPWT) devices. Priority 2 – Warning Warning
06/11/2014 Insulin Infusion Pumps. Priority 3 – Advisory Advisory
05/11/2014 Summary of Field Safety Notices – October 2014 3rd Party Publications
22/10/2014 TELIGENTM implantable cardioverter defibrillators (ICD) and COGNISTM cardiac resynchronisation therapy devices (CRT-D). Priority 2 – Warning Warning
20/10/2014 Accu-Chek Spirit Combo Insulin pump (Model No. 00700006863). Priority 2 – Warning Warning
03/10/2014 Servo-i Ventilator Battery Modules. Part Numbers: 6487180. Manufacturing Dates: 1005- 1243 (February 1, 2010 – October 25, 2012) Priority 2 – Warning Warning
02/10/2014 Summary of Field Safety Notices – September 2014 3rd Party Publications
26/09/2014 Liko SlingBar 350, SlingBar 360, SlingBar Wide 670, SideBar Standard. Part Numbers: 3156015, 3156002, 3156008,3156004, 3156013, 3156012, 3156017 or 3156011. Distributed between April 1998 and May 2008. Priority 2 – Warning Warning
08/09/2014 Tosoh Automated Glycohemoglobin Analyzers: HLC-723G7 (Variant Analysis Mode) & HLC-723G8 (Variant Analysis Mode) Priority 2 – Warning Warning
03/09/2014 Summary of Field Safety Notices – August 2014 3rd Party Publications
12/08/2014 Trauma External Fixation System (Small, Medium, Distraction Osteogensis (DO) Ring and Large). Priority 2 – Warning Warning
11/08/2014 ArjoHuntleigh lifting poles with an adjustable strap and handle. Priority 3 – Advisory Advisory
07/08/2014 Field Safety Notices- July 2014 3rd Party Publications