Field Safety Notices - 24 - 28 October 2016

Summary List of field safety notices (FSNs) from medical device manufacturers from 24 - 28 October 2016

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

B. Braun Melsungen: UREOFIX 500 CLASSIC

24 October 2016

Urine collection devices and accessories

Model: 4417930, 4417920, 4417910

MHRA reference: 2016/010/026/291/009

Bellco: Formula, Formula Plus, Formula 2000, Formula 2000 Plus, Formula Therapy, Formula Domus

October 2016

Dialysis, haemodialysis

MHRA reference: 2016/010/021/291/017

Brainlab: BrainLAB Knee

23 September 2016

Surgical navigation system

MHRA reference: 2016/010/024/701/009

Inpeco: Aptio and FlexLab by Inpeco

25 October 2016

IVDs, clinical chemistry

MHRA reference: 2016/010/026/601/010

Intuitive Surgical: da Vinci® Xi™ Surgical System

20 October 2016

Endoscopes, rigid

Model: IS4000 Surgical System 380677 / SS4000 380652 / PS4000

MHRA reference: 2016/010/021/701/014

Medtronic: SynchroMed® II Implantable Drug Pumps

October 2106

Implants, active, infusion pumps

Model: 8637-20, 8637-40

MHRA reference: 2016/010/021/291/014

Medtronic: Charging System, RestoreSensor Charging System

FA735

Implants, active, stimulators, neuro

Model: Model 37751 Recharger included in Model 37651 Charging System for Deep Brain Stimulation (DBS), Activa RC (Model 37612)

MHRA reference: 2016/010/026/291/001

Molnlycke Healthcare: ProcedurePak trays containing Light Handle Cover (Devon™ Light Glove)

24 October 2016

Surgical devices, non-powered

MHRA reference: 2016/010/026/291/007

Nipro Corporation: SFS-5-25P

24 October 2016

Infusion & transfusion, connectors

MHRA reference: 2016/010/024/291/036

Siemens Healthcare:ADVIA Centaur Vitamin D Total

11 October 2016

IVDs, clinical chemistry

Model: 100 Test kit SMN 10699201; 500 Test kit SMN 10699533

MHRA reference: 2016/010/011/601/003

Siemens Healthcare: Combi Dockable Table Neurosurgery

10 October 2016

Magnetic resonance, equipment & accessories

Model: 10684336 / 10684337

MHRA reference: 2016/010/011/601/005

Siemens Healthcare: Chemistry Calibrator

11 October 2016

IVDs, clinical chemistry

MHRA reference: 2016/010/011/601/006

Siemens Healthcare: ADVIA 560 Hematology System

24 October 2016

IVDs, haematology

Model: SMN 11170842

MHRA reference: 2016/010/024/601/006

Signus: ROTAIO, cervical disc replacement prosthesis

07 September 2016

Spinal implants

MHRA reference: 2016/010/024/291/003

Spacelabs: Xhibit Central Station

18 October 2016

Monitors, patient

Model: 96102

MHRA reference: 2016/010/025/291/011

St. Jude Medical: Nanostim Leadless Cardiac Pacemaker (LCP) system

28 October 2016

Implants, active, pacemakers

MHRA reference: 2016/010/027/291/016

Trinity Biotech: MicroTrak® Syphilis TPHA

21 October 2016

IVDs, bacteriology

MHRA reference: 2016/010/024/291/025

Trinity Biotech: MicroTrak® RPR Syphilis

21 October 2016 - R019-16 - MicroTrak® RPR Syphilis

IVDs, bacteriology

MHRA reference: 2016/010/024/291/026

Zimmer: Java Posterior stabilization System

19 October 2016

Orthopaedic surgical instruments - Insertion/extraction tools

Model: SN2023-1-00401

MHRA reference: 2016/010/020/291/013

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