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
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:
Abbott: HeartMate 3 Coring Tool
08 March 2019
Implantable ventricular assist devices Model: 10005872 HeartMate 3 Coring Tool
MHRA reference:
B Braun: Certofix庐 Quattro
11 March 2019
Vascular cannula and catheters
MHRA reference:
BEAVER-VISITEC INTERNATIONAL: The Beaver庐 Micro Knife 5.0mm 30掳
19 February 2019
Surgical instruments, non-articulated cutting
MHRA reference:
Beckman Coulter: DxA 5000
13 March 2019
IVDs, clinical chemistry
MHRA reference:
Biomet: LactoSorb RapidFlap
12 March 2019
Osteosynthesis, bone plates
MHRA reference:
Dr. Ebeling & Assoc (Medovent): Reaxon (Reaxon Direct, Reaxon Nerve Guide)
05 March 2019
Implants, non-active, neurosurgical
MHRA reference:
Draeger: Infinity Acute Care System (M540)
March 2019
Monitors, patient
MHRA reference:
Elekta: Elekta Unity
February 2019
Radiotherapy
MHRA reference:
GE: Logiq P5 and Logiq A5
13 March 2019
Ultrasound, imaging
BT06/BT08
MHRA reference:
Hamilton: HAMILTON-C6 Ventilator
21 February
Lung ventilators 160021
MHRA reference:
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:
NOXBOX
08 March 2019
Lung ventilators
MHRA reference:
Olympus: MAJ-209 SINGLE USE SUCTION VALVE
March 2019
Endoscopes, flexible
Model: MAJ-209
MHRA reference:
Ortho-Clinical: VITROS XT7600
March 2019
IVDs, clinical chemistry
MHRA reference:
Randox Laboratories: Liquid Cardiac Control
07 March 2019
IVDs, clinical chemistry
Model: CQ5051, CQ5052, CQ5053
MHRA reference:
Siemens: SOMATOM Confidence, Edge Plus, Definition Edge, AS
08 March 2019
Computed tomography
Model: 8098027, 102670000, 10590000, 10590100
MHRA reference:
Siemens: Atellica Solution
March 2019
IVDs, clinical chemistry
MHRA reference:
Smiths Medical: Portex庐 Bivona庐 Inner Cannula Tracheostomy Tube
21 February 2019
Airway devices
Model: BRC270, BRC275, BRC280, BRC285, BRC290, BRCA70, BRCA75, BRCA80, BRCA85, BRCA90
MHRA reference:
Thermofisher Scientific: MAS ChemTRAK H Assayed Control Level 3
05 March 2019
IVDs, clinical chemistry
MHRA reference:
Vyaire Medical: enFlow Disposable IV Fluid/Blood Warmer Cartridge
FSCA-2019-0001_VY
Blood/fluid warming systems
MHRA reference:
Waldemar Link: MP-Prosthesis stem, XS-0, L=160
23 November 2018
Joint prosthesis, hip
MHRA reference:
Wright Medical Technology:577000DG
06 March 2019
Orthopaedic surgical instruments - measuring tools
Model: MICA
MHRA reference: