Field safety notices - 21 - 25 May 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 21 to 25 May 2018.
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
Beckman Coulter: AQUIOS CL Flow Cytometer System
05 March 2018
IVDs, haematology
Model: Not Applicable
MHRA reference: 2017/009/001/601/014
Biomet (Zimmer): Comprehensive Shoulder Instrument Outer Case
16 May 2018
Orthopaedic surgical instruments
MHRA reference: 2018/005/017/701/001
Coherex Medical: WaveCrest LAA OCCL SYS 32MM
07 May 2018
Implants, non active, cardiac appendage
MHRA reference: 2018/005/018/478/011
Cook Medical: Cook Multi-Use Holmium Laser Fibers
May 2017
Therapy, lasers
MHRA reference: 2017/006/014/291/003
Depuy Synthes: CORAIL® AMT Neck Segments
PIE-1125109
Joint prosthesis, hip
Model: L94003, L94004, L94005, L94006 and L94007.
MHRA reference: 2018/005/023/478/016
MatOrtho:Medial Rotation Knee (MRK) Knee System
26 April 2018
Joint prosthesis, knee
MHRA reference: 2018/004/019/601/017
MATZ Medical Ltd: OHYON
2018/004/023/401/011
Injection devices
Model: MML_SY_92
MHRA reference: 2018/004/023/401/011
Medos Medizintechnik (Xenios): Deltastream HC, NovaTherm& i-cor TCU
May 2018
Heart lung machines
MHRA reference: 2016/007/026/299/003
PerkinElmer: AutoDELFIA
21 May 2018
IVDs, clinical chemistry
MHRA reference: 2018/005/021/478/022
Radiometer: ABL90 FLEX
15 May 2018
IVDs, extra laboratory testing
Model: 393-090
MHRA reference: 2018/005/009/228/006
Randox Laboratories: Liquid Assayed Specific Protein Controls
03 May 2018
IVDs, clinical chemistry
Model: PS2682, PS2683, PS2684
MHRA reference: 2018/005/008/601/005
Siemens Healthcare: AXIOM Artis/Artis zee
15 May 2018
X Ray, fluoroscopy systems
MHRA reference: 2018/005/022/601/012
Siemens Healthcare: ARTIS pheno
23 April 2018
X Ray, fluoroscopy systems
Model: see enclosure
MHRA reference: 2018/005/017/601/003
Siemens Healthcare: Artis zee/Q/Q.zen systems
24 April 2018
X Ray, fluoroscopy systems
MHRA reference: 2018/005/018/601/003
Siemens Healthcare: ADVIA Centaur XPT
May 2018
IVDs, clinical chemistry
MHRA reference: 2017/002/007/601/003
Smith & Nephew: D-Rad Smart Pack 4 Hole Right Standard Plate
14 May 2018
Osteosynthesis, bone plates
MHRA reference: [2018/005/016/701/016
Stryker: QuickFlap, Neuro Implants
May 2018
Osteosynthesis, bone plates
MHRA reference: 2018/005/015/701/025
Surgical Innovations: Quick Dissect
22 May 2018
Surgical, diathermy
Model: Q21205
MHRA reference: 2018/005/023/701/014
Thermo Fisher Scientific: ThermoScientific™ Oxoid™ Mueller Hinton Broth
14 February 2018
IVDs, bacteriology
Model: CM0405B
MHRA reference: 2018/003/009/601/005