Field Safety Notice: 11 to 15 March 2019

List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 March 2019

Overview

If you receive a field safety notice (FSN) from a manufacturer you must always act on it.

MHRA publishes the following for information only.

If you have a question about a particular FSN contact the manufacturer.

Latest FSNs

View the latest FSNs

Abbott

07 March 2019

IVDs, clinical chemistry 03R70-01: Alinity ci-series System Control Module (SCM) - GMDN 56701

04S68-01: Level Sensor, Bulk Solution

03R66-01/03R66-02: Accessory kit, Alinity i

03R69-01/03R69-02: Accessory kit, Alinity c

MHRA reference: 2019/003/011/701/013

Abbott: HeartMate 3 Coring Tool

08 March 2019

Implantable ventricular assist devices Model: 10005872 HeartMate 3 Coring Tool

MHRA reference: 2019/003/004/291/031

B Braun: Certofix® Quattro

11 March 2019

Vascular cannula and catheters

MHRA reference: 2019/003/012/601/002

BEAVER-VISITEC INTERNATIONAL: The Beaver® Micro Knife 5.0mm 30°

19 February 2019

Surgical instruments, non-articulated cutting

MHRA reference: 2019/003/012/701/007

Beckman Coulter: DxA 5000

13 March 2019

IVDs, clinical chemistry

MHRA reference: 2019/003/013/601/005

Biomet: LactoSorb RapidFlap

12 March 2019

Osteosynthesis, bone plates

MHRA reference: 2019/003/012/291/021

Dr. Ebeling & Assoc (Medovent): Reaxon (Reaxon Direct, Reaxon Nerve Guide)

05 March 2019

Implants, non-active, neurosurgical

MHRA reference: 2019/003/007/601/011

Draeger: Infinity Acute Care System (M540)

March 2019

Monitors, patient

MHRA reference: 2019/003/014/291/001

Elekta: Elekta Unity

February 2019

Radiotherapy

MHRA reference: 2019/003/012/291/007

GE: Logiq P5 and Logiq A5

13 March 2019

Ultrasound, imaging

BT06/BT08

MHRA reference: 2019/003/007/291/007

Hamilton: HAMILTON-C6 Ventilator

21 February

Lung ventilators 160021

MHRA reference: 2019/003/012/487/009

LivaNova: Heater-cooler 3T

07 March 2019

Blood/fluid warming systems 16-02-80, 16-02-81, 16-02-82, 16-02-83, 16-02-85

MHRA reference: 2019/003/008/487/004

NOXBOX

08 March 2019

Lung ventilators

MHRA reference: 2019/003/012/601/010

Olympus: MAJ-209 SINGLE USE SUCTION VALVE

March 2019

Endoscopes, flexible

Model: MAJ-209

MHRA reference: 2019/003/014/291/007

Ortho-Clinical: VITROS XT7600

March 2019

IVDs, clinical chemistry

MHRA reference: 2019/003/012/601/005

Randox Laboratories: Liquid Cardiac Control

07 March 2019

IVDs, clinical chemistry

Model: CQ5051, CQ5052, CQ5053

MHRA reference: 2019/003/008/601/006

Siemens: SOMATOM Confidence, Edge Plus, Definition Edge, AS

08 March 2019

Computed tomography

Model: 8098027, 102670000, 10590000, 10590100

MHRA reference: 2019/003/008/601/010

Siemens: Atellica Solution

March 2019

IVDs, clinical chemistry

MHRA reference:2019/003/011/601/004

Smiths Medical: Portex® Bivona® Inner Cannula Tracheostomy Tube

21 February 2019

Airway devices

Model: BRC270, BRC275, BRC280, BRC285, BRC290, BRCA70, BRCA75, BRCA80, BRCA85, BRCA90

MHRA reference: 2019/003/008/487/001

Thermofisher Scientific: MAS ChemTRAK H Assayed Control Level 3

05 March 2019

IVDs, clinical chemistry

MHRA reference: 2019/003/011/487/010

Vyaire Medical: enFlow Disposable IV Fluid/Blood Warmer Cartridge

FSCA-2019-0001_VY

Blood/fluid warming systems

MHRA reference: 2019/003/013/291/001

23 November 2018

Joint prosthesis, hip

MHRA reference: 2018/011/026/701/002

Wright Medical Technology:577000DG

06 March 2019

Orthopaedic surgical instruments - measuring tools

Model: MICA

MHRA reference: 2018/005/003/401/009

Updates to this page

Published 18 March 2019