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

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