Field Safety Notice: 02 to 06 December 2019
List of field safety notices (FSNs) from medical device manufacturers from 02 to 06 December 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
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3M Deutschland: Durapore鈩� Advanced Surgical Tape
27 November 2019
Bandages and tapes
MHRA reference:
Abbott Medical: HeartMate 3鈩� Left Ventricular Assist System
02 December 2019
Implantable ventricular assist devices
Model: MPU: 107758, HM3 LVAS Kit: 106524INT, 106524
MHRA reference:
Abbott Medical UK: HeartMate 3鈩� Left Ventricular Assist System
02 December 2019
Ventricular 鈥� pump
Model: 106525, 106525INT / 106524, 106524INT LVAS HM3 KIT
MHRA reference:
AMO (Johnson & Johnson): Healon GV PRO
05 December 2019
Implants, non active, intraocular
MHRA reference:
BioM茅rieux: VIDAS VARICEL. ZOSTER IGG 60 T
November 2019
IVDs, viral microbiology
MHRA reference:
Convatec: FLUTED SILICONE ROUND DRAINS CH15 & CH1
29 November 2019
Wound drains
MHRA reference:
Dexcom: Dexcom G6 iOS CGM Ap
02 December 2019
Continuous glucose monitoring systems (CGMS)
Model: SW11585, SW11586
MHRA reference:
DXC Technology: i.Laboratory (Apex) AKI
20 November 2019
IVDs, clinical chemistry
MHRA reference:
Edwards Life Sciences: Quickdraw - Peripheral venous access cannula
FCA152
Vascular cannula and catheters
Model: QD22, QD25
MHRA reference:
Insignia Medical Systems: Insignia Insight PACS - Patient Explorer 2
21 November 2019
Picture archiving and communication system (PACS)
MHRA reference:
Medline Industries: CHARGER BASE, UK PLUG
12 November 2019
Surgical equipment, miscellaneous
MHRA reference:
Microvention: Detachable Azur Peripheral Coil System
FCA201903
Detachable azur peripheral coil system
MHRA reference:
Microvention: MicroPlex and HydroCoil Embolic System
FCA201904
Embolisation coils
MHRA reference:
NAL VON MINDEN: NADAL庐 hCG Pregnancy Test
29 December 2019
IVDs, extra laboratory testing
MHRA reference:
ResMed: Stellar 100/ Stellar 150
05 December 2019
Lung ventilators
Model: 100, 150
MHRA reference:
Siemens Healthcare: Atellica CH 930 Analyzer
November 2019
IVDs, clinical chemistry
MHRA reference:
SLE: SLE6000 Infant Ventilator
28 November 2019
Lung ventilators
MHRA reference:
Stryker Trauma: Delta Strike Plate IMN Instruments
06 December 2019
Osteosynthesis, nails intramedullary
MHRA reference:
Van Oostveen Medical: Romed IV Catheters With Injection Por
25 November 2019
Vascular cannula and catheters
Model: IVCATH-(size), Romed IV Catheters With Injection Port
MHRA reference:
ViewRay: Stereotacticradiotherapy/MRI System
3011233554-11-18-2019-003-C
Magnetic resonance, equipment & accessories
Model: MRIdian Linac System
MHRA reference:
VISAMED (Gettinge): Sensation Plus 7.5Fr 40cc
29 May 2019
Cardiac assist pumps
Model: 0684-00-5658-01
MHRA reference:
Wallac Oy: GSP Neonatal IRT kit
28 November 2019
IVD, genetic testing
Model: 3306-0010
MHRA reference: