Field Safety Notice: 15 to 19 April 2019
List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 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
Abbott: BranAlinity c Cuvette Segment
15 April 2019
IVDs, clinical chemistry
MHRA reference: 2019/004/017/487/006
Accuray: CyberKnife Treatment Delivery System
08 April 2019
Radiotherapy
MHRA reference: 2019/004/016/701/005
Cardinal Health
15 April 2019
Dover Silicone Foley Catheter 5CC 12fr/16fr/20fr
Dover Silicone Foley Catheter 30CC 24fr
Argyle Universal Green Bubble Tubing 3mm x 30m
Argyle Flexible Yankauer Catheter 18fr
Argyle Flexible Yankauer Catheter fine capacity 12fr
Argyle Thoracic Catheter Straight 28fr
Argyle Thoracic Catheter Right Angle 32fr
MHRA reference: 2019/004/016/291/004
Codman- Depuy Synthes: Concorde Lift
April 2019
Spinal implants
197809221C, 197809226C, 197811221C, 197811226C,
MHRA reference: 2019/004/015/291/015
FormAlign: AquAlign Tilting Showerchair
10 April 2019
Bath and aids
1 FGA4001
MHRA reference: 2019/004/012/291/002
Grifols: Procleix HEV Assay
10 April 2019
IVDs, viral microbiology
MHRA reference: 2019/004/011/701/035
Intuitive Surgical: da Vinci® Xi™ and da Vinci® X™ Surgical System
ISIFA2019-02-C
Endoscopes, rigid
MHRA reference: 2019/004/017/701/016
Impromediform (BD): MaxZero™ Needleless Connector
17 April 2019
Infusion & transfusion, connectors
MHRA reference: 2019/004/015/701/013
Linkage Biosciences: SureTyper Software
15 April 2019
IVDs, clinical chemistry
STTPGRX
MHRA reference: 2019/004/017/701/017
Medtronic: Sherpa Active 6F Guide Catheter
FA864
Vascular cannula and catheters
See FSN
MHRA reference: 2019/004/015/291/029
Stanmore: JTS PROXIMAL FEMORAL
11 April 2019
Joint prosthesis, knee
Patient Specific Device
MHRA reference: 2019/004/012/291/007
Occlutech: Occlutech Delivery Set
16 April 2019
Implants, non-active, cardiac appendage and septal defect occluders / plugs
MHRA reference: 2019/004/017/487/010
Samsung Electronics: GM85
FSCA-GM85_190326-1
X Ray, mobiles
MHRA reference: 2019/004/015/291/011