Field Safety Notice - 12 to 16 February 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 February 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
3M Health Care: 3M™ Surgical Clipper Professional
09 February 2018
Surgical Equipment, Miscellaneous
MHRA reference: 2018/002/014/478/013
Beckman Coulter: AQUIOS CL Flow Cytometer System
05 February 2018
IVDs, haematology
MHRA reference: 2018/002/012/601/002
BERCHTOLD GmbH & Co. KG (Stryker): ChromoView Monitor carrier arm
February 2018
Lamps & Lights
Model: CT 0604004, CT 0604104, CT 0605004, CT 0605104, CT 0606104
MHRA reference: 2018/002/008/701/013
Chalice Medical:Paragon
05 February 2018
Heart Lung Machines
Model: Oxygenators
MHRA reference: 2018/002/005/601/002
Covidien llc: Barrx™ 360 Express RFA Balloon Catheter
February 2018
Therapy Tissue Ablation
MHRA reference: 2018/002/015/291/012
FUJIFILM: FUJIFILM 7000 Video Processor
ECN-G1723
Endoscopes, televisual systems
Model: VP-7000
MHRA reference: 2018/002/014/478/010
GCMedica Enterprise (Wuxi): Uterine Aspiration Tube
07 February 2018
Surgical Equipment, Miscellaneous
MHRA reference: 2018/002/008/478/001
GE Healthcare Integrated IT Solutions: Centricity Universal Viewer
85442
Picture Archiving And Communication System (PACS)
MHRA reference: 2018/002/012/291/009
Illumina: MiSeqDx Cystic Fibrosis 139-Variant Assay (2 Run)
13 February 2018
IVD, genetic testing
Model: PN 15036580
MHRA reference: 2018/002/013/601/006
Life Technologies Corporation: Fetal Hemoglobin Monoclonal Antibody (HBF-1), FITC
05 February 2018
IVDs, Blood Transfusion
MHRA reference: 2018/002/015/291/011
MAKO Surgical (Stryker): Restoris® MCK Onlay Insert Extractor
February 2018
Orthopaedic Surgical instruments - Insertion/extraction tools
MHRA reference: 2018/001/026/701/013
Medtronic:Bio-Cal Temperature Controller
February 2018
Blood/fluid warming systems
Model: 370, 370I
MHRA reference: 2018/002/012/478/004
Micromed SpA: CAR POLE (component of BQ and BRAIN QUICK series)
07 February 2018
Monitors, patient
Model: 400.041.0000
MHRA reference: 2018/002/012/291/008
NxStage Medical: NxStage PureFlow SL SAK
29 January 2018
Dialysis, Haemodialysis
Model: SAK-303, SAK-304, SAK-30
MHRA reference: 2018/002/012/291/007
NxStage Medical: NxStage PureFlow SL SAK
29 January 2018
Dialysis, haemodialysis
Model: NxStage PureFlow SL SAK
MHRA reference: 2018/002/014/291/007
Omixon Biocomputing: Omixon HLA Twin CE
24 January 2018
IVD, genetic testing
MHRA reference: 2018/001/029/228/004
Philips Medical Systems (Andover): Philips SureSigns VSi / SureSigns VS2+
January 2018
Monitors, Patient
Model: SureSigns VSi: 863275, 863276, 863277
SureSigns VS2+: 863278, 863279
MHRA reference: 2018/002/012/478/003
XO Care A/S: Dental unit XO 4
26 October 2017
Dental Appliances / Instruments
Model: X04
MHRA reference: 2018/001/031/228/009