Field Safety Notice: 25 to 29 November 2019

List of field safety notices (FSNs) from medical device manufacturers from 25 October to 29 November 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

Ambu: King Vision video Laryngoscope

08 November 2019

Airway devices

Model: King Vision video Laryngoscope, KVLVA12

MHRA reference: 2019/011/021/291/007

Applied Medical: Python®, BARD Latex-free, Over-the-Wire latis®

November 2019

Vascular cannula and catheters

Model: A4EXX, A4GW6 and CE0XXXDR

MHRA reference: 2019/011/021/701/026

Edwards Lifesciences: HemoSphere Oximetry Cable

FCA 148

Monitors, patient

Model: HEMOXSC100

MHRA reference: 2019/011/021/701/027

GE: CARESCAPE Respiratory Modules (E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE) and the Airway Gas Option (N-CAiO)

FMI 36141

Anaesthetic machines & monitors

MHRA reference: 2019/011/020/701/017

impedimed: 292-DTE

08 November 2019

ECG

MHRA reference: 2019/011/021/291/001

Maquet (Getinge): Volista STANDOP, Volista TRIOP

20 November 2019

Lamps & lights

MHRA reference: 2019/004/024/487/017

Mavidon Medical Products: LemonPrep

13 September 2019

ECG

MHRA reference: 2019/011/025/291/010

Medtronic: O-arm™ O2 Imaging System

November 2019

X Ray, fluoroscopy systems

Model: BI-700-02000 O-arm O2 Base

MHRA reference: 2019/011/022/291/016

Philips Respironics: Trilogy Evo, Garbin Evo, LifeVent Evo2

November 2019

Lung ventilators

Model: DE2100X13B, DE2110X13B, EE2110X15B, ES2100X15B, ES2110X15B, EU2100X15B, EU2110X15B, FR2110X14B, GB2110X15B, IN2100X15B, IN2110X15B, IT2100X21B, LD2110X23B, ND2110X15B, SP2100X26B 

MHRA reference: 2019/011/021/291/006

Roche: Accu-Chek® Aviva, Performa BGM

06 November 2019

IVDs, self / home testing

MHRA reference: 2019/011/006/701/008

Siemens Healthineers: Cios Alpha

November 2019

X ray, fluoroscopy systems

Model: Cios Alpha systems with a specific material number

MHRA reference: 2019/011/026/601/001

Smith & Nephew: PROFIX 750 Gr. Mallet Cleaning&Sterilization Guide

C-2019-11

Surgical devices, non-powered

MHRA reference: 2019/011/026/701/011

Stanmore: Special (Custom) Tibial Augment (METS SMILES TKR)

22 November 2019

Joint prosthesis, knee

Model: N/A- Patient Specific Device

MHRA reference: 2019/011/025/291/014

Published 2 December 2019