Field Safety Notice: 11 to 15 March 2019
List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 March 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
07 March 2019
IVDs, clinical chemistry 03R70-01: Alinity ci-series System Control Module (SCM) - GMDN 56701
04S68-01: Level Sensor, Bulk Solution
03R66-01/03R66-02: Accessory kit, Alinity i
03R69-01/03R69-02: Accessory kit, Alinity c
MHRA reference: 2019/003/011/701/013
Abbott: HeartMate 3 Coring Tool
08 March 2019
Implantable ventricular assist devices Model: 10005872 HeartMate 3 Coring Tool
MHRA reference: 2019/003/004/291/031
B Braun: Certofix® Quattro
11 March 2019
Vascular cannula and catheters
MHRA reference: 2019/003/012/601/002
BEAVER-VISITEC INTERNATIONAL: The Beaver® Micro Knife 5.0mm 30°
19 February 2019
Surgical instruments, non-articulated cutting
MHRA reference: 2019/003/012/701/007
Beckman Coulter: DxA 5000
13 March 2019
IVDs, clinical chemistry
MHRA reference: 2019/003/013/601/005
Biomet: LactoSorb RapidFlap
12 March 2019
Osteosynthesis, bone plates
MHRA reference: 2019/003/012/291/021
Dr. Ebeling & Assoc (Medovent): Reaxon (Reaxon Direct, Reaxon Nerve Guide)
05 March 2019
Implants, non-active, neurosurgical
MHRA reference: 2019/003/007/601/011
Draeger: Infinity Acute Care System (M540)
March 2019
Monitors, patient
MHRA reference: 2019/003/014/291/001
Elekta: Elekta Unity
February 2019
Radiotherapy
MHRA reference: 2019/003/012/291/007
GE: Logiq P5 and Logiq A5
13 March 2019
Ultrasound, imaging
BT06/BT08
MHRA reference: 2019/003/007/291/007
Hamilton: HAMILTON-C6 Ventilator
21 February
Lung ventilators 160021
MHRA reference: 2019/003/012/487/009
LivaNova: Heater-cooler 3T
07 March 2019
Blood/fluid warming systems 16-02-80, 16-02-81, 16-02-82, 16-02-83, 16-02-85
MHRA reference: 2019/003/008/487/004
NOXBOX
08 March 2019
Lung ventilators
MHRA reference: 2019/003/012/601/010
Olympus: MAJ-209 SINGLE USE SUCTION VALVE
March 2019
Endoscopes, flexible
Model: MAJ-209
MHRA reference: 2019/003/014/291/007
Ortho-Clinical: VITROS XT7600
March 2019
IVDs, clinical chemistry
MHRA reference: 2019/003/012/601/005
Randox Laboratories: Liquid Cardiac Control
07 March 2019
IVDs, clinical chemistry
Model: CQ5051, CQ5052, CQ5053
MHRA reference: 2019/003/008/601/006
Siemens: SOMATOM Confidence, Edge Plus, Definition Edge, AS
08 March 2019
Computed tomography
Model: 8098027, 102670000, 10590000, 10590100
MHRA reference: 2019/003/008/601/010
Siemens: Atellica Solution
March 2019
IVDs, clinical chemistry
MHRA reference:2019/003/011/601/004
Smiths Medical: Portex® Bivona® Inner Cannula Tracheostomy Tube
21 February 2019
Airway devices
Model: BRC270, BRC275, BRC280, BRC285, BRC290, BRCA70, BRCA75, BRCA80, BRCA85, BRCA90
MHRA reference: 2019/003/008/487/001
Thermofisher Scientific: MAS ChemTRAK H Assayed Control Level 3
05 March 2019
IVDs, clinical chemistry
MHRA reference: 2019/003/011/487/010
Vyaire Medical: enFlow Disposable IV Fluid/Blood Warmer Cartridge
FSCA-2019-0001_VY
Blood/fluid warming systems
MHRA reference: 2019/003/013/291/001
Waldemar Link: MP-Prosthesis stem, XS-0, L=160
23 November 2018
Joint prosthesis, hip
MHRA reference: 2018/011/026/701/002
Wright Medical Technology:577000DG
06 March 2019
Orthopaedic surgical instruments - measuring tools
Model: MICA
MHRA reference: 2018/005/003/401/009