Field Safety Notice - 30 April to 04 May 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 30 April to 04 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
Abbott: various
23 April 2018
Implants, active, defibrillators
Cardioverter Defibrillator (Icd)
MHRA reference: 2018/004/020/478/005
Alere Technologies: Alere Afinion ACR Control
24 April 2018
IVDs, clinical chemistry
MHRA reference: 2018/004/020/291/003
Apollo Endosurgery: BIB/Orbera/Orbera365 Intragastric Balloon Systems
April 2018
Implants, non active, gastrointestinal
B-40800, B-50000, B-50012
MHRA reference: 2018/004/030/478/010
Biomet (Zimmer): Phoenix Tibia Nail, 3.5 mm Inserter Connector
02 May 2018
Orthopaedic surgical instruments - insertion/extraction tools
MHRA reference: 2018/005/003/478/011
Cytocell: cMYC (MYC) Breakapart
20 April 2018
IVD, genetic testing
MHRA reference: 2018/004/025/701/026
GE Vingmed Ultrasound AS/Healthcare: Vivid 7, Vivid E7, Vivid E9, Vivid E80 / Vivid E90 / Vivid E95
70219
Ultrasound, Imaging
MHRA reference: 2018/004/011/478/001
Intuitive Surgical: da Vinci® Xi™ EndoWrist® Stapler 45 Reload
ISIFA2018-04-C
Staples and staple guns
48645B-03; 48445G-03
MHRA reference: 2018/004/027/701/010
Philips: IntelliVue MX40 Patient Monitor
April 2018
Multi parameter monitor
MHRA reference: 2018/005/003/478/007
Roche Diagnostics: MagNA Pure 24 System
26 April 2018
IVDs, viral microbiology
07290519001 03337138001 03337154001 03313522001
MHRA reference: 2018/004/027/701/006
Thermo Fisher Scientific: Oxoid
19 April 2018
IVDs, bacteriology
CT0159B
MHRA reference: 2018/004/024/601/004