Field Safety Notice: 4 to 8 February 2019

List of field safety notices (FSNs) from medical device manufacturers from 4 to 8 February 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: ARCHITECT Estradiol Reagent Kit Alinity i Estradiol Reagent Kit

05 February 2019

IVDs, clinical chemistry

MHRA reference: 2019/002/006/701/011

Applied Medical: CFF05 5x75mm Kii Fios Advanced Fixation Access Sys

January 2019

Surgical instruments, minimal access CFF05

MHRA reference: 2019/002/006/291/007

Arthrex: Burr, Oval, 12 Flute, 5.5 mm x 13 cm

R519_UK Surgical power tools

AR-8550OBT

MHRA reference: 2019/001/024/487/006

Boston Scientific: ACCOLADE, ALTRUA 2, ESSENTIO, PROPONENT, VALITUDE, VISIONIST

January 2019

Implants, active, pacemakers

MHRA reference: 2017/012/019/291/016

Boston Scientific: VALITUDE™, VISIONIST™ CRT-P and CHARISMA™ , MOMENTUM™, RESONATE™, VIGILANT™, AUTOGEN™, DYNAGEN™, INOGEN™, ORIGEN™ CRT-D

January 2019

Implants, active, cardiac

MHRA reference: 2017/012/019/291/018

Drive DeVilbiss: Forearm Crutches

07 January 2019

Walking aids, crutches

MHRA reference: 2018/011/021/401/001

Edwards Life Sciences: Edwards Commander Delivery System

FCA 123

Implants, non-active, cardiovascular heart valves

9600LDS20A, 9600LDS20J, 9600LDS23A, 9600LDS23J, 9600LDS26A, 9600LDS26J, 9600LDS29A, 9600LDS29J, 9610TF20, 9610TF23, 9610TF26, 9610TF29

MHRA reference: 2019/002/006/291/009

Elekta: Monaco RTP System

February 2018

Radiotherapy planning and verification systems

MHRA reference: 2019/002/006/701/020

JRI Orthopaedics: Cemented Acetabular Cups

25 January 2019

Joint prosthesis, hip

Model: 02-28-XX

MHRA reference: 2019/001/021/601/001

Johnson & Johnson: Ethicon Ethibond Excel Suture, Size 2-0

01 February 2019

Sutures

MHRA reference: 2019/002/004/291/008

Pall Life Sciences: Ultipor 25 / Breathing System Filter

04 February 2019

Breathing system components

MHRA reference: 2019/002/004/701/009

Penlon: MAC 3 Penlon

04 February 2019 Airway devices

MHRA reference: 2018/009/004/401/012

Randox Laboratories: Immunoassay Premium Plus Controls

REC369

IVDs, clinical chemistry

Model: Immunoassay Premium Plus Controls IA3109 & IA3112

MHRA reference: 2019/002/001/601/004

Rhondium: OVC3

01 February 2019

Implants, dental

Model: 1. OVC3 24/25 L A2

MHRA reference: 2019/001/030/487/009

Siemens: Acuson NX2, NX2 Elite, NX3, NX3 Elite

US038/18/S

Ultrasound, imaging

Model: 11284381,11362069,11235612,11235411

MHRA reference: 2019/002/005/601/006

Spacelabs: Smart Disclosure

28 January 2019

Monitors, patient

Model: 92810

MHRA reference: 2019/002/004/291/011

US Endoscopy Group: Padlock Clip defect closure system

01 February 2019

Clip appliers

Model: C910001

MHRA reference: 2019/002/004/701/001

WallacOy: DELFIA / AutoDELFIA hCG Kit

08 January 2019

IVDs, clinical chemistry

Model: A082-101/ B082-101, A007-101 / B007-101 and B007-112

MHRA reference: 2019/001/007/291/007

Published 11 February 2019