Field Safety Notices - 15 to 19 June 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 15 to 19 June 2020

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

View a list of FSNs published since January 2020

View FSNs since November 2014. FSNs before this date are on the National Archives website

Arcomed: VP7000

01 June 2020

Infusion systems

Model: Chroma, Premium

MHRA reference: 2020/006/015/487/001

Biotronik AG: Passeo-18 Lux

200000375

Vascular cannula and catheters

MHRA reference: 2020/006/010/487/003

Boston Scientific: ELUVIA™ Over-The-Wire (OTW) Drug-Eluting Vascular Stent System

92489879-FA

Vascular cannula and catheters

MHRA reference: 2020/006/010/487/002

Breas: Protective Cover Vivo 55/65

06 February 2020

Lung ventilators

MHRA reference: 2020/002/006/487/014

Datex-Ohmeda (GE Healthcare): Giraffe Omnibed, Giraffe Incubator

FMI 32076

Infant incubators

MHRA reference: 2020/005/019/291/004

Ethicon Endo-Surgery: PERMAHAND™ Silk Suture

16 June 2020

Sutures

MHRA reference: 2020/006/009/487/007

Medtronic: Console IPC-ENT, Master Console EC300, Powerease IPC, Microdebrider M5

June 2020

Surgical power tools

Model: Console:1898001, EC300, 2340000 Handpiece: 1899200

MHRA reference: 2020/006/016/291/002

Natus: Olympic Brainz Monitor

02 March 2020

Monitors, patient

Model: OBM00002

MHRA reference: 2020005/001/601/005

OrthoPediatrics: ACL Reconstruction System - ShieldLoc

06 June 2020

ligaments, tendons and anchors

Model: 10-1008-4060 & 10-1008-4070

MHRA reference: 2020/006/010/701/028

Siemens: Chemistry Calibrator

June 2020

IVDs, clinical chemistry

MHRA reference: 2020/006/012/601/001

Spectranetics: Stellarex - OTW Drug-coated Angioplasty Balloon

D056663

Vascular cannula and catheters

MHRA reference: 2020/006/009/601/005

Teleflex: Lasertube (Rubber) Laser resistant tracheal tube, cuffed; Endotracheal tube for laser surgery

18 June 2020

Airway devices

MHRA reference: 2020/006/018/487/011

Wellspect: LoFric Origo, 40cm

16 June 2020

Urinary catheters and accessories

Model: 44310, 44316, 44410, 44414

MHRA reference: 2020/006/016/601/003

Published 22 June 2020