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

Updates to this page

Published 23 April 2019