Medical Device Field Safety Notices

Ensuring Public Safety Through Transparency and Vigilance

Field Safety Notices (FSNs) are crucial communications issued by manufacturers or authorized representatives when a medical device presents a potential safety issue or requires corrective action. These notices are vital to maintaining the safety, quality, and effectiveness of medical devices in the healthcare system.

What Are Field Safety Notices?

• Purpose: To inform healthcare professionals, Economic Operators, and users about identified risks associated with a medical device and the measures to mitigate those risks.
• Scope: FSNs may include product recalls, corrective actions, or updates to the device's use instructions.
• Compliance: All FSNs are issued in accordance with EU and Maltese regulations to ensure a coordinated and effective response.

How We Manage FSNs

The Malta Medicines Authority collaborates with manufacturers, distributors, and healthcare providers to:

• Monitor and manage the dissemination of FSNs.
• Ensure prompt and appropriate action is taken to address identified risks.
• Provide clear guidance on the steps required to maintain patient safety.
• Track and report the implementation of corrective actions to verify compliance.

Accessing Field Safety Notices

We maintain an up-to-date repository of all Field Safety Notices related to medical devices available in Malta. This ensures transparency and provides healthcare professionals and the public with access to critical safety information.

Your Role in Medical Device Safety

Healthcare providers and users are encouraged to stay informed about FSNs and promptly act on any recommendations to mitigate potential risks. Reporting any concerns or incidents involving medical devices contributes to the continuous improvement of safety measures.

For further assistance or inquiries about Field Safety Notices, contact the Medical Device and Pharmaceutical Collaboration Directorate at devices.medicinesauthority@gov.mt.

March 2025

ZOLL Powerheart® G5 AED Product Family

Medtronic A71400 RC Clinician Programmer

Welch Allyn non-automated blood pressure gauges

Radiometer ABL90 FLEX and ABL90 FLEX PLUS

Ge HealthCare Start Scan MR System

B Braun Single Needle Cross Over/Single Needle Bloodlines for Dialog and Dialog iQ dialysis machines

Medtronic Evolut™ PRO /FX/FX Bioprosthesis

February 2025

Intersurgical Various uniflow coaxial breathing systems

BD Alaris™ GP Guardrails™ Volumetric Pump

Roche Elecsys® anti-TPO

Medline infusion/transfusion sets

Smiths Medical Intubation ORAL/NASAL Endotracheal Tube

Abbott ASSURITY™ AND ENDURITY™ PACEMAKERS

Hedia Diabetes Assistant

January 2025

Icu medical Medima Infusion Pump

Icu Medical Medima P100, P200, and P300

Da Vinci X and Xi Grip Cable Failures

Da Vinci X and Xi Pitch Cable Failures

Dexcom G6 Receiver

Pro-Lab Diagnostics Grams Staining Kit

Agilent Technologies pharmDx Kit

Werfen ROTEM sigma

Zimmer Biomet Optipac®

PENTAX MEDICAL Video Processor EPK-i8020c and i20c

Aesculap AG Sterilization Containers

Exmoor Plastics Limited Nasal Splints

Didactic INFINEED Infusion Devices

Elekta MOSAIQ

Getinge Heater-Cooler Unit

Medtronic MiniMed Insulin Pumps

Philips MR systems

Philips SENSE XL Torso

Philips AD7 and AD7x

December 2024 

Permobil SpeedControl Dial

Coloplast catheters

Smiths Medical Tracheal Tube Reusable Introducer and Guides

Siemens Healthineers N Latex RF Kits

Boston Scientific ACCOLADE

BD PCR Cartridge

GE HealthCare Nuclear Medicine systems 

Eclipse Medical ChekFLO Vascular Plugs

November 2024 

Smiths Medical Tracheal Tube Reusable Introducer and Guides

Ultragel Medical kft AquaUltraClear transmission ultrasound gel

Rocket Medical Thoracentesis Catheter

Medtronic SynchroMed ™A810 Clinician Programmer Software

BD FACSLyric™ Flow Cytometers

OMEGA Left Atrial Appendage (LAA) Occluder Device

Advanced Medical Solutions Silvercel Hydro Alginate

October 2024 

Baxter TruSystem 7000

Medtronic MiniMed 600 and 700 series

Baxter MiniCap Extended Life PD transfer

Getinge Universal Remote Control

Baxter MiniCap Extended Life PD transfer Luer Transfer Sets

Philips MR system breast coils

September 2024 

GE HealthCare Centricity PACS System

Smiths Medical Nasopharyngeal

Philips Respironics Trilogy Evo, Trilogy Evo O2, Trilogy EV300

Integra Codman® Surgical Patties & Strips

B. Braun Nutrifix Bag and Infusomat

Siemens Healthineers IMMULITE 2000

Werfen HemosIL® Rinse Solution

Philips Zenition 50 and Zenition 70 systems

Philips MR system breast coils

August 2024

Atellica CI, Atellica IM and ADVIA Centaur CA 19-9 Bias

GE HealthCare Anesthesia Devices

Boston Scientific Vercise Genus Deep Brain Stimulation

BioMérieux VITEK® 2

Grifols Erytra-Eflexis Analyzer

Pennine Healthcare Intermittent Standard Nelaton Catheter

Alcon DAILIES TOTAL

Olympus HIGH FLOW INSUFFLATION UNIT

Smith & Nephew REGENETEN Tendon Anchors

Shimadzu SIL-40 Series

Medtronic Vanta™ Implantable Neurostimulator

ACUSON Juniper and Maple

Advanta VXT and Flixene Vascular Grafts with Slider GDS

July 2024

corPatch easy

Thermofisher scientific Oncomine® Dx Express Test Panel

Philips Trilogy Evo, Trilogy Evo O2, and Trilogy EV300

Bruker Daltonics UMIC Colistin

Exmoor Plastics Ltd Aural Vent Tubes

Exmoor Plastics Ltd Silicone Sheets, Discs and Strips

Robinson Health Care Fast Aid Zinc Oxide Tape

Convatec Kaltostat (R) Wound Dressing & Rope

Elekta Unity Systems

Alcon A-OK 20G V-LANCE FULL HANDLE1.3MM SATIN Bn. 15W9CJ

BD Phoenix™ M50 & BD Phoenix™ 100 Instruments

McGRATH™ MAC Video Laryngoscope

June 2024

Smiths Medical Bivona® Tracheostomy Tubes

Terumo Spectra Optia Apheresis System

Siemens Healthineers Atellica IM Analyzer & ADVIA Centaur XPT System

Hologic Horizon X-Ray Bone Densitometer (DXA)

GE HealthCare MR Systems

ZOLL G5 Semi-Automatic AED Product Family

Philips Wired Avalon Ultrasound Transducer

Baxter iLED 7 Surgical Lights

SLE6000 Infant Ventilator

Medtronic Cobalt XT™, Cobalt™ and Crome™ ICD

Boston Scientific Capio SLIM Suture Capturing Device

May 2024

Carescape multi-parameter patient monitors

MyoSPECT and MyoSPECT ES Systems

Medtronic Ascenda™ Intrathecal catheters

Idylla™ EGFR Mutation Test

Integra CUSA® Handpiece

Radiometer BL800 Basic and ABL8XX FLEX analyzers

Mindray BeneHeart D1 Automated External Defibrillator

Medtronic Magnetic Resonance Imaging (MRI) Eligibility status

April 2024

STRYKER EXETER 2.5 I M PLUG

Medtronic Vanta™ Implantable Neurostimulator

HeartSine Samaritan PAD and Omron HDF-3500

Intersurgical Various Mapleson F Anaesthetic Breathing Systems

Vercise Genus™ Deep Brain Stimulation (DBS)

Fabian HFO Classic and Fabian HFOi ventilators

Infinity M500 Docking Station

JENX Supine 2 and Multistander 2

IONA® Nx cfDNA Library Preparation Dx Kit

Randox Total Bilirubin Vanadate Oxidation Method

Philips MR systems

Fisher & Paykel Airvo 2 and myAirvo 2 devices

Perrigo Physiomer Baby Unidose

March 2024

Covidien Auto Suture™ Structural Balloon Trocar & Auto Suture™ Blunt Tip Trocar

Randox Calibration Serum Level 3

Philips Trilogy Evo - Loss of Power Alarm

DiaMed/Bio-Rad Reagents for antibody screening tests

Karex Medline Endocavity 

Resmed Astral  100 and Astral 150 ventilator

Philips MR room cage installations

Philips OmniLab Advanced (OLA )

February 2024

Lentismed HYDROPHILIC URINARY CATHETER LENTY

Masimo TC- I Reusable Tip Clip sensors

Genedrive MT-RNR1 ID Kit

EMP Allergy Eye Mist

DiaMed/Bio-Rad IH-500

Asset Medical FLOWART® NEEDLE FREE VALVE SET WITH 1.2 MICRON FILTER

January 2024 

Medtronic Shiley™ Adult Flexible Tracheostomy Tube

Getinge Maquet SAS

Zimmer Dermacarriers TM II Skin Graft Carriers

Philips Trilogy Evo

ACE BLADDER EVACUATOR

Duet® External Drainage and Monitoring System (EDMS)

August 2021

Philips Respironics CPAP and Bi-Level PAP Devices

Philips Respironics Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models