Field Safety Notices - 11 July - 15 July 2016
Summary List of field safety notices (FSNs) from medical device manufacturers from 11 - 15 July 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
View the latest FSNs
DEAS: DEAS Autofeed Humidification Chamber
16 June 2016
Humidifiers
Model: DEAS Autofeed Humidification Chamber 1035609
MHRA reference: 2016/007/012/291/017
Elekta: Radiotherapy
FCA-IMS-0015 Radiotherapy
Model: MOSAIQ
MHRA reference: 2016/007/013/299/003
Ellex: Integre-S
01 March 2016
Therapy, lasers Model: LP5532
MHRA reference: 2016/003/009/601/007
Hill-Rom: Progressa® BED SYSTEM
MOD1249
Mattresses - active/passive and overlays
Model: Progressa® Bed system P7500A
MHRA reference: 2016/007/004/291/021
In2Bones SAS: I.B.S Snap-off screw
21 June 2016
Osteosynthesis, bone screws
Model: S27 ST012
MHRA reference: 2016/006/027/291/020
Medset Medizintechnik: ECG-Top amplifier
25 M
ECG MHRA reference: 2016/006/028/291/006
MicroPort Orthopedics: ADVANCE® HA Coated
7 July 2016
Joint prosthesis, knee
MHRA reference: 2016/007/004/701/018
MicroPort Orthopedics: Metal on Metal - Total Hip Arthroplasty (THA) indication
7 July 2016
Joint prosthesis, hip
MHRA reference: 2016/007/004/291/019
Miele: washer/disinfector
20 June 2016
Cssd wash/clean/drying equipment
Model: PG88XX with XX = {21, 22, 25, 30} and PG89YY with YY = {22, 30}
MHRA reference: 2016/007/012/291/004
Natus: neoBLUE LED Phototherapy System
June 2016
Therapy, infant phototherapy
Model: 010066, 010068, 010069, 010070
MHRA reference: 2016/007/012/291/005
Neurodan: ActiGait® Implantable Drop Foot Stimulator
20 June 2016
Implants, active, stimulators, neuro
Model: 453
MHRA reference: 2016/007/005/701/024
Philips: Allura Xper and UNIQ
20 June 2016
X Ray, fluoroscopy systems
Model: Allura Xper and UNIQ 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722038, 722039, 722058, 722059 with release R8.2 (Allura Xper) or R1.0 (UNIQ)
MHRA reference: 2016/007/007/291/010
Randox: Lipase
17 June 2016
IVDs, clinical chemistry
MHRA reference: 2016/007/007/601/008
Roche: Accu-Chek Performa Nano
8 July 2016
IVDs, self / home testing
Model: 06454348018
MHRA reference: 2016/007/008/701/013
Roche: see below under "Accessories"
06 July 2016
IVDs, extra laboratory testing
Model: cobas b123 <3> POC system, Model No. 05122279001
cobas b123 <4> POC system, Model No. 05122287001
MHRA reference: 2016/007/008/701/011
Siemens: Artis systems with 19" Live Display
6 June 2016
X Ray, fluoroscopy systems
MHRA reference: 2016/007/014/601/005
The Binding Site: Optilite Freelite Lambda Kit
5 July 2016
IVDs, immunology
Model: LK018.OPT
MHRA reference: 2016/007/006/601/010
Thermofisher Scientific: ThermoScientificTM Oxoid™ Columbia Blood Agar Base
7 July 2016
IVDs, bacteriology
Model: CM0331
MHRA reference: 2016/007/008/601/007
Varian Medical Systems: TrueBeam® & EDGE™ Radiotherapy Delivery Systems
24 June 2016
Radiotherapy
Model: TrueBeam® & EDGE™ Radiotherapy Delivery Systems H19
MHRA reference: 2016/007/008/701/001
bioMérieux: NucliSENS® easyMAG® Magnetic Silica
11 July 2016
IVDs, viral microbiology
MHRA reference: 2016/007/012/291/009
bioMérieux: Mueller Hinton + 5 % horse blood agar + 20 mg/l bêta-NAD
21 June 2016
IVDs, bacteriology
MHRA reference: 2016/006/021/291/003
bioMerieux: VIDAS® Estradiol II
7 July 2016
IVDs, clinical chemistry
Model: Reagent/ Assay
MHRA reference: 2016/007/011/299/002