Field Safety Notices - 5 - 9 September 2016
Summary List of field safety notices (FSNs) from medical device manufacturers from 5 - 9 September 2016
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
Abbott Medical Optics: Refer to Section 8
August 2016
Implants, non-active, intraocular
Model: various models
MHRA reference: 2016/008/031/701/012
Alba Bioscience: ALBAcyte® A2 Cells REAGENT RED CELLS
31 August 2016
IVDs, blood transfusion
MHRA reference: 2016/008/031/601/012
Animas Corporation: Animas Insulin Pumps
19 September 2016
Infusion systems
MHRA reference: 2016/009/002/291/020
Biocartis: Idylla™ KRAS Mutation Test
1 September 2016
IVD, genetic testing
MHRA reference: 2016/009/002/701/006
DFS-Diamon: solder and wire for laser welding for dental prosthesis
2 September 2016
Dental materials
MHRA reference: 2016/009/002/291/021
Ecolab: Klerpack BD Syringe Multi-Pack
2 September 2016
Injection devices
Model: 3038080, 3038090, 3038110, 3038120, 3039820, 3039830, 3039840, 3039850, 3039870, 3039880, 3039920, 3039940, 3040080, 3040100, 3039910, 3040000, 3058710, 3038100, 3058720, 3040070, 3040060, 3039980, 3039960, 3039890, 3039900, 3040120
MHRA reference: 2016/009/006/701/005
Etac: Molift Air 205 & 3000
6 July 2016
Hoists and slings
MHRA reference: 2016/006/029/291/016
Fresenius: CATSmart 9005751
5 September 2016
Infusion & transfusion, autologous
MHRA reference: 2016/009/006/299/014
GE healthcare: SIGNA Creator/ SIGNA Explore
FMI 67921
Magnetic resonance, equipment & accessories
MHRA reference: 2016/009/005/701/017
GE Medical: MAGiC application running on some GEHC MR systems M70012RM
FMI 60903
Magnetic resonance, equipment & accessories
Model: MAGiC application running on some GEHC MR systems
MHRA reference: 2016/009/005/701/018
Getinge Lancer: ED-FLOW AER, ED-FLOW SD AER
16 August 2016
Cssd wash/clean/drying equipment
Model: 01280004, 01280010, 01280012, 01280014, 01280015.
MHRA reference: 2016/009/005/299/011
Merit Medical: Drip Chamber
1721504-08/11/16-003-R
Vascular cannula and catheters
MHRA reference: 2016/008/029/701/009
Philips: Brilliance BR64 Ingenuity CT Ingenuity Core Ingenuity Core128
26 August 2016
Computed tomography
Model: Brilliance BR64 (728231) Ingenuity Core (728321) Ingenuity Core128 (728323) Ingenuity CT (728326)
MHRA reference: 2016/009/008/299/006
Radiometer: ABL90 FLEX and ABL90 PLUS
FAN 915-353
IVDs, Extra Laboratory Testing
MHRA reference: 2016/009/007/701/008
Randox: IgE
28 July 2016
IVDs, immunology
Model: Calibrators
MHRA reference: 2016/009/005/601/003
Robinson Healthcare: Instrapac
8 September 2016
Dental syringes and needles
MHRA reference: 2016/009/007/701/007
Shenzhen: Dryline II Water Trap
August 2016
Anaesthetic machines & monitors
MHRA reference: 2016/008/030/291/023
Siemens: Dimension & Dimension Vista IRON Flex reagen
September 2016
IVDs, clinical chemistry
Model: Dimension & Dimension Vista IRON Flex reagent. DF85 Dimension Iron K3085 Dimension Vista Iron
MHRA reference: 2016/009/008/601/008
Siemens: RAPIDPoint 400, 450 Measurement Cartridge
September 2016
IVDs, extra laboratory testing
MHRA reference: 2016/009/005/601/005
Spacelabs Healthcare: UVSL Command Module
1 July 2016
Monitors, patient
Model: UVSL Command Module 91496
MHRA reference: 2016/007/012/131/003
Teleflex Medical: EZIO Manual Driver
1 September 2016
Orthopaedic surgical instruments - Insertion/extraction tools
MHRA reference: 2016/009/005/299/008
Unisurge International: Formula Procedure Packs
ASCF2016-09-006
Surgical, diathermy
Model: F300073 / F300079 / F300088 / F300096 / F300106 / F300197 / F301031 / F301200 / F301404 / F600486 / F700038 / F700092
MHRA reference: 2016/009/006/601/004