Field Safety Notice - 3 to 7 July 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 3 to 7 July 2017
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
Beckman Coulter: COULTER LH 750 Analyzer; LH 780 Analyzer; LH500 Analyzer; HmX CP Analyzers; HmX AL Analyzers
29 June 2017
IVDs, haematology
MHRA reference:
Boston Scientific: Fractional Flow Reserve (FFR) Link
5 July 2017
Ultrasound, Imaging
Model: H7495551000
MHRA reference:
Cardiac Pacemaker: EMBLEM鈩� S-ICDs, EMBLEM鈩� MRI S-ICDs and SQ-RX鈩� S-ICDs
30 June 2017
Implants, active, defibrillators
Model: EMBLEM S-ICD (A209, A219), SQ-RX (1010)
MHRA reference:
Chalice Medical: Paratherm
23 June 2017
Blood/fluid warming systems
MHRA reference:
Cosman Medical: Nitinol TC Reusable Electrodes
June 2017
Therapy tissue ablation
Model: TCN-5-3M, TCN-10-3M, TCN-15-3M, TCN-5, TCN-10, TCN-15, TCN-20, TCNK-5, TCNK-5-C, TCNK-10,TCNK-10-C, TCNK-15, TCNK-15-C, TCNK-20
MHRA reference:
Cyberonics: VNS Therapy庐 AspireSR庐 and AspireHC庐 Generator
30 June 2017
Implants, active, stimulators, neuro
Model: VNS Therapy庐 AspireSR庐 and AspireHC庐 Generator; 106, 105
MHRA reference:
Depuy Synthes: Impactor for PFNA Blade
21 April 2017
Orthopaedic surgical instruments - impacting tools
Model: Impactor for PFNA Blade; 03.010.410
MHRA reference:
Guangzhou Fortunique: SPY-PHI Drape HH2020, HH2000
26 June 2017
Surgical drapes, gowns, masks
MHRA reference:
Helica Instruments: Helica
CAR3 TC568
Surgical, diathermy
Model: Helica; Thermal Coagulator
MHRA reference:
Horiba Medical: HORIBA ABX
20 June 2017
IVDs, haematology
Model: Yumizen H500 CT
MHRA reference:
Mindray: WATO EX-65, WATO EX-55, A5 and A7
June 2017
Anaesthetic machines & monitors
MHRA reference:
Novo Nordisk: NovoPen庐 Echo庐 and NovoPen庐 5
03 July 2017
Insulin injection devices
MHRA reference:
One Lambda: AllSet+鈩� Gold SSP
27 June 2017
IVDs, immunology
MHRA reference:
Ossur: Halo Vest/Lil Angel Halo Vest
10 April 2017
Orthoses
Model: 545700L, 545100L, 545800L, 545100K, 545700K 545100S, 545800K 545150K, 545700S 545150L, 545800S 545150S
MHRA reference:
R82: Heron
30 June 2017
Bath and aids
Model: 880505-01; 880505-11
MHRA reference:
Reha: G-EO System
2017-001
Therapy, standing & walking
Model: G-EO System
MHRA reference:
Roche: Elecsys Digoxin
28 June 2017
IVDs, clinical chemistry
MHRA reference:
Siemens Healthcare:
29 May 2017
X Ray, fluoroscopy systems
MHRA reference:
Siemens: Symbia S, Symbia T, Symbia Intevo
28 June 2017
Nuclear medicine, gamma camera systems & accessories
Model: 10275007, 10275008, 10764804, 8717741
MHRA reference:
Stanmore: JTS Grower Drive Unit
4 July 2017
Joint prosthesis, knee
Model: MLE 3
MHRA reference:
Updates to this page
-
Updated link to FSN for Siemens: Symbia S, Symbia T, Symbia Intevo (MHRA Ref: 2017/005/019/601/013)
-
First published.