Field Safety Notice: 8 to 12 April 2019
List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 April 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
Cellnovo Group
28 March 2019
This company has gone into administration. The group has discontinued all manufacturing and commercial activities.
Please refer to the letter sent to customers and the press release: https://www.cellnovo.com/press-releases
MHRA reference: 2019/004/005/223/002
A.R.C. Laser: Wolf with a wavelength of 445nm
29 March 2019
Therapy, lasers
MHRA reference: 2019/004/008/291/005
Abbott: Alinity i Processing Module
05 April 2019
IVDs, clinical chemistry
MHRA reference: 2019/004/009/701/024
Apollo Healthcare Technologies: Pandora Profiling Bed
05 April 2019
Beds and accessories APH031
MHRA reference: 2019/004/008/291/001
Biomet (Zimmer): T7 Driver AO
10 April 2019
Orthopaedic Surgical instruments - Insertion/extraction tools
MHRA reference: 2019/004/010/291/016
Boston Scientific: Auriga™ XL 4007 & Auriga™ 30 Laser System
09 April 2019
Therapy, lasers
M0068FS4007G0 – Auriga XL 4007 General System
MHRA reference: 2019/004/009/291/019
Dornier: Dornier Standard Diode and Nd:YAG Lightguides
05 April 2019
Therapy, lasers
MHRA reference: 2019/004/005/291/024
EKOS Corp: EKOS Control System 4.0 - Connector interface cabl
27 March 2019 Ultrasound, imaging
MHRA reference: 2019/004/005/291/018
Fannin: Blood agar No 2 + Horse Blood & Staph/ Strep Selective Agar Mofified
03 April 2019 IVDs, bacteriology
MHRA reference: 2019/004/005/601/004
Fresenius: CompoStop® Systems
20 March 2019
Storage & collection devices
MHRA reference: 2019/003/021/601/014
GE: Precision 500D
FMI 10927
X Ray, fluoroscopy systems
MHRA reference: 2019/004/009/291/015
Integra LifeSciences: Joint Prosthesis, Toe
08 April 2019
Joint prosthesis, toe MGT-890-10MT; MGT-890-20MT; MGT-890-30MT
MHRA reference: 2019/003/029/487/003
JRI Orthopaedics: ACE Trial Cup
08 April 2019
Joint prosthesis, hip 051-44-00 & 051-50-00
MHRA reference: 2019/004/008/291/006
Leonhard Lang (Schiller) Customer: Schiller Defibrillation Electrode
11 April 2019
Defibrillators, non-implantable
0-21-0003, 0-21-0020, 2.155061, 2.155065, 2.155063, 0-21-0037,
MHRA reference: 2019/004/011/701/019
Leonhard Lang (Schiller) Distributor: Schiller Defibrillation Electrode
11 April 2019
Defibrillators, non-implantable
0-21-0003, 0-21-0020, 2.155061, 2.155065, 2.155063, 0-21-0037,
MHRA reference: 2019/004/011/701/019
Molnlycke Health Care: Neurosurgical procedure kits
04 April 2019
Surgical devices, non-powered
MHRA reference: 2019/004/005/291/023
Olympus Surgical Technologies America: Diego Elite Shaver Blade
11 April 2019
Surgical power tools
MHRA reference: 2019/004/009/291/017
Ortho-Clinical: VITROS Chemistry Products CK Slides
April 2019
IVDs, clinical chemistry
MHRA reference: 2019/004/010/601/012
Philips: MobileDiagnost wDR
08 March 2019
X ray, mobiles
Model: 712001,712002, 712004, 712005
MHRA reference: 2019/004/003/291/001
Philips: IntelliVue MX40 Patient Monitor
19 June 2019
Monitors, patient
MHRA reference: 2019/004/011/291/024
Rifton: TRAM / E PACER QUICK RELEASE BUCKLES
007 – FSCA
Moving & handling TRAM - K310 & K320 / E PACER -K660
MHRA reference: 2019/004/008/291/011
Teleflex: Lasertube (Rubber) Laser resistant tracheal tube, cuffed; Endotracheal tube for laser surgery
10 April 2019
Airway devices MHRA reference: 2019/004/010/291/024
Therakos (Mallinckrodt): Apheresis
09 August 2018
Photopheresis kit Cellex Photopheresis System
MHRA reference: 2018/009/014/291/002
Thermo Fisher: Oxoid
05 April 2019
IVDs, bacteriology
Model: MA0122
MHRA reference: 2019/004/008/601/008