Field Safety Notice: 20 to 25 May 2019
List of field safety notices (FSNs) from medical device manufacturers from 20 to 25 May 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: Alinity c
16 May 2019
IVDs, clinical chemistry
MHRA reference: 2019/005/020/701/014
Abbott: Architect
16 May 2019
IVDs, clinical chemistry
MHRA reference: 2019/005/020/701/013
Abbott: MitraClip XTR Delivery System
1 May 2019
Implants, non-active, cardiovascular heart valves CDS0602-XTR
MHRA reference: 2019/004/029/291/006
Biomet Zimmer: Oxford Knee Anatomic Meniscal Bearing
21 May 2019
Joint prosthesis, knee
MHRA reference: 2019/005/021/487/006
EDAP TMS: Sonolith i-sys
05 December 2018
Lithotripsy, external and internal
MHRA reference: 2019/005/016/291/004
EKF-diagnostic: Quo-Lab A1C Test Kit / PocketChem HbA1Cc Test Kit
21 May 2019
IVDs, extra laboratory testing
MHRA reference: 2019/005/021/701/018
Edwards Lifesciences: Intro-Flex® Percutaneous Sheath Introducers
FCA 132
Vascular cannula and catheters I355BF9
MHRA reference: 2019/005/021/701/010
Medtronic: O-arm 1000 Imaging System
May 2019
X Ray, fluoroscopy systems
MHRA reference: 2019/005/015/291/002
Medtronic: My Therapy App for Sacral Neuromodulation Therapy
May 2019
Implants, active, stimulators, neuro A510
MHRA reference: 2019/005/016/487/007
Neuromedex GmbH: Brand
14 May 2019
SECURODRAIN / NeuroVac flat silicone drainage 01.3404, 01.3454, 21-0411 and 23-0411
MHRA reference: 2019/005/015/291/001
Pennine Healthcare: Pennine Intro-Uri-Cath
22 May 2019
Urinary catheters and accessories
MHRA reference: 2019/005/020/291/003
Shimadzu Corporation: FDR Go DR-ID 800
14 December 2018
X Ray, mobiles
MHRA reference: [2019/005/020/701/018]https://mhra-gov.filecamp.com/s/IX25zeuPbNETqQLo/d)
Stanmore: Femoral Heads
19 February 2019
Joint prosthesis, hip
msfmh/cc28-3.5
MHRA reference: 2019/002/019/487/019
Thermo Fisher: Tests based on NAD(H)/NADP(H) reaction, see cat.no
16 May 2019
IVDs, clinical chemistry
MHRA reference: 2019/005/023/487/009
Von Ardenne Institut für Angewandte Medizinische Forschung: IRATHERM1000
09 April 2019
Heating, patient, electrical pads & blankets
MHRA reference: 2019/005/017/291/001
Xhale Assurance: Nasal Alar SpO2 Sensor
May 2019
Monitors, patient
MHRA reference: 2019/005/011/701/004