Field Safety Notices - 23 - 27 May 2016
Summary List of field safety notices (FSNs) from medical device manufacturers from 23 - 27 May 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
ArjoHuntleigh: Akron Echo 2
05 April 2016
Trolleys and chairs
Model: Akron Echo 2 A5962, A5972
MHRA reference: 2016/003/017/701/015
BBI Solutions: SimpliRED D-Dimer
26 May 2016
Coagulation
Model: DSRK4
MHRA reference: 2016/005/023/601/007
ConMed: ThermoGard Dual Dispersive Electrodes
25 May 2016
Surgical, diathermy
MHRA reference: 2016/005/023/701/015
Depuy Synthes: Flexible Shaft Ø 8.0mm, L 360 mm
18 May 2016
Osteosynthesis, nails intramedullary
Model: Flexible Shaft Ø 8.0mm, L 360 mm for Extraction System for Solid Medullary Nails 351.430
MHRA reference: 2016/005/025/299/005
Edwards Lifesciences: Edwards Commander Delivery System
20 May 2016
Vascular cannula and catheters
Model: 9610TF23, 9610TF26, 9610TF29
MHRA reference: 2016/005/020/701/021
GE Healthcare Medical: Optima MR430s, MSK Extreme MR Scanner
FMI 60899
Magnetic resonance, equipment & accessories
MHRA reference: 2016/005/020/299/030
HeartWare: HeartWare Ventricular Assist System
24 May 2016
Implantable ventricular assist devices
Model: 1400, 1407XX
MHRA reference: 2016/005/024/291/012
Invacare: FOX
16 May 2016
Wheelchairs, powered
MHRA reference: 2016/004/028/701/014
Johnson & Johnson: ETHICON PHYSIOMESH™ Flexible Composite Mesh
25 May 2016
Implants, non-active, abdominal & hernia mesh
MHRA reference: 2016/005/025/701/005
LiNA: LiNA Fetal Scalp Blood Sampler
10 March 2016
Storage & collection devices
Model: 4201-BCI, 4201-BR
MHRA reference: 2016/003/011/601/004
Medfact Engineering: FIRMap catheter
03 May 2016
Therapy tissue ablation
MHRA reference: 2016/005/024/291/005
Medtronic: Coronary stent- Bare Metal
May 2016
Implants, non-active, coronary artery stents
MHRA reference: 2016/005/013/291/012
Medtronic: Midas Rex
# ® Sagittal Saws
May 2016
Surgical power tools
Model: ES300, ES300-R, ES310, ES310-R.
MHRA reference: 2016/005/023/299/018
One Lambda: AllSet+™ Gold SSP
06 May 2016
IVDs, haematology
MHRA reference: 2016/005/023/299/008
One Lambda: UniTray SSP HLA Typing Kits
06 May 2016
IVDs, immunology
MHRA reference: 2016/005/025/291/008
Randox: RX daytona plus - RX4040/RX4041
18 May 2016
IVDs, clinical chemistry
MHRA reference: 2016/005/020/601/004
Roche: Vancomycin: products see below under “Accessories”
13 May 2016
IVDs, bacteriology
Model: Antimicrobial Suscepitibility Testing
MHRA reference: 2016/005/023/701/013
Roche: ONLINE TDM Gentamicin 100 Tests, ONLINE TDM Gentamicin 100 Tests, ONLINE TDM Gentamicin Mod.
23 May 2016
IVDs, bacteriology
MHRA reference: 2016/005/025/071/001
Siemens: Stratus CS 200 Acute Care™ Diagnostics System
May 2016
IVDs, clinical chemistry
MHRA reference: 2016/005/026/601/004
Thermofisher: K671411-2
5 May 2016
IVDs, bacteriology
MHRA reference: 2016/005/005/601/003
X-spine: Calix Trials and Rasps
23 May 2016
Spinal implants
MHRA reference: 2016/005/024/601/001
Zimmer Biomet: Hip and Trauma Implant Screws
19 May 2016
Osteosynthesis, bone screws
MHRA reference: 2016/005/020/701/015
Zimmer: Cephalomedullary Femoral Nail
23 May 2016
Osteosynthesis, nails intramedullary
Model: Cephalomedullary Femoral Naillong 11.5mm X 30cm 130 CCD Left TI-6AL-4V; Cephalomedullary Femoral Nail - Long 13mm X 30cm 125 CCD Right TI-6AL-4V
MHRA reference: 2016/005/023/701/014