Field Safety Notice - 18 April to 21 April 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 18-21 April 2017
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 SHBG Reagent Kit
18 April 2017
IVDs, clinical chemistry MHRA reference: 2017/004/019/701/023
Beckman Coulter: AQUIOS CL Cytometer
13 April 2017
IVDs, haematology
Model: AQUIOS CL Cytometer
MHRA reference: 2017/004/013/601/007
CooperSurgical: Inflatoball Pessary
10 April 2017
Implants, non active, implantable
Model: MXPINFS - MXPINFM - MXPINFL - MXPINFXL
MHRA reference: 2017/004/012/701/007
DENTSPLY Sirona: Implant Driver P EV 4.2 Long
11 April 2017
Orthopaedic surgical instruments - insertion/extraction tools
Model: Implant Driver P EV 4.2 Long
MHRA reference: 2017/004/012/701/020
Gambro: ARTIS 230V, EVOSYS 230V, ARTIS AFBK, ARTIS 230V Physio, ARTIS 230V Physio LP, ARTIS AFBK Physio, ARTIS 230V LP
April 2017
Dialysis, haemodialysis
Model: ARTIS 230V, ARTIS 230V Physio (110635 110648 114389 115323 115324 115326 15401)
MHRA reference: 2017/004/018/291/008
Hoya Corporation (PENTAX MEDICAL): Endoscope diverse: not limited to a specific device
FSCA-PE-16-001
Endoscopes, flexible
MHRA reference: 2017/001/006/299/020
HS: AMICA GEN
11 April 2017
Therapy tissue ablation
Model: AGN-H-1.0 - AGN-3.0 - AGN-R-1.0
MHRA reference: 2017/004/019/701/019
HSDU: ESHT
11 April 2017
Surgical devices, non-powered
Model: genesis boxes
MHRA reference: 2017/004/013/299/025
Karma Medical Products: Karma
31 March 2017
Wheelchairs, manual
Model: KM-8522HD
MHRA reference: 2017/004/003/299/011
Mahe Medical: Mercian Surgical Supply
14 April 2017
Osteosynthesis, bone screws
Model: SP3006-14
MHRA reference: 2017/004/020/601/001
Maxter Catheters: ENTRAL ENFit™ nasogastric feeding tubes - Ranges NST, SFT, AND DFT
29 March 2017
Feeding systems and tubes
MHRA reference: 2017/003/007/291/023
Medtronic: SynchroMed® II Implantable Drug Pumps
April 2017
Implants, active, infusion pumps
Model: 8637-20, 8637-40
MHRA reference: 2017/004/013/299/006
Miele & Cie: PG 8527, PG 8528, PG 8535, PG 8536
M001/17
Cssd wash/clean/drying equipment
MHRA reference: 2017/004/012/701/005
Nexstim: Nexstim NBS System
14 March 2017
Surgical navigation system
Model: NBS System 4, NBS System 5
MHRA reference: 2017/004/012/701/016
Rand Srl: Hang&Go kits, HIPP(F)
13 April 2017
Blood/fluid warming systems
MHRA reference: 2017/004/018/291/010
RENISHAW: neuromate stereotactic system
07 April 2017
Surgical navigation system
Model: all
MHRA reference: 2017/004/018/701/019
Schwarzer CardioTek: EP-TRACER
6 April 2017
Diagnostic measurement and monitoring
Model: EP-TRACER 38, EP-TRACER 70, EP-TRACER 102
MHRA reference: 2017/004/013/701/014
Siemens: All Sensis systems
20 March 2017
ECG
MHRA reference: 2017/004/013/601/006
Siemens: IMMULITE / IMMULITE 2000 LBP
April 2017
IVDs, viral microbiology
Model: LKLB1 10381395 / L2KLB2 10381474
MHRA reference: 2017/004/003/601/001
Stryke: PKG, EDS LIGHT SUSP CENTRAL AXIS, INT, FP/9P/5P
April 2017
Lamps & lights
Model: Visum 0682-001-570i
MHRA reference: 2017/004/019/701/012