Field safety Notice - 8 August to 12 August

Summary List of field safety notices (FSNs) from medical device manufacturers from 8 - 12 August 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

Bayer: Medrad® Stellant with Certegra Workstation

August 2016

Media Injectors

Model: Certegra® Workstation used in conjunction with Medrad® Stellant® CT Injection System

MHRA reference: 2016/008/008/701/009

Beckman Coulter: UniCel DxH Slidemaker Stainer (SMS)

8 August 2016

IVDs, haematology

MHRA reference: 2016/008/008/601/007

Boston Scientific: Uphold™ LITE Vaginal Support System with Capio™ SLIM, PinnacleTM LITE Pelvic Floor Repair Kit, Posterior with CapioTM SLIM, Upsylon™ Y Mesh Kit with Colpassist™ Vaginal Positioning Device

06 June 2016

Implants, non-active, implantable incontinence and prolapse devices

MHRA reference: 2016/006/002/291/014

Boston Scientific: Advantage™ and Advantage Fit™ System, Transvaginal Sling, Lynx™ System, Suprapubic Sling Obtryx™ System, (Curved or Halo), Transobturator Sling, Obtryx™ II System with PrecisionBlue™ Design, (Curved or Halo), Transobturator Sling, Solyx™ SIS System, Single Incision Sling

06 June 2016 - 91130383-FA - Mesh Slings

Implants, non-active, implantable incontinence and prolapse devices

MHRA reference: 2016/008/001/291/003

Boston Scientific: • Xenform™ Soft Tissue Repair Matrix

06 June 2016 - 91130383-FA - Xenform

Implants, non-active, implantable incontinence and prolapse devices

Model: M0068302410, M0068302430, M0068302450, M0068302470

MHRA reference: 2016/008/001/291/002

09 August 2016

IVDs, viral microbiology

MHRA reference: 2016/008/010/299/004

Elekta

200 01 103 061

Radiotherapy

Model: Machine numbers 105345 to 151764

MHRA reference: 2016/008/004/701/012

LeMaitre Vascular: Hydro LeMaitre Valvulotome

09 August 2016

Surgical instruments, non-articulated cutting

Model: 1009-00, 1009-00J

MHRA reference: 2016/008/009/701/012

MedXpert: Strasbourg Thorax Osteosyntheses System

02 November 2015

Osteosynthesis, bone plates

MHRA reference: 2016/007/026/291/002

Mediplus: Chalfont connector

10 August 2016

Infusion & transfusion, administration sets

MHRA reference: 2016/008/011/701/016

Nutricia: Flocare Infinity II Enteral feeding pump

11August 2016

Feeding systems and tubes

Model: 35676 / 35679 / 35682 / 35685 / 35677 / 35680 / 35683

MHRA reference: 2016/008/010/299/006

ResMed: Astral 150

12 August 2016

Lung ventilators

MHRA reference: 2016/008/002/291/002

Siemens: syngo RT Therapist TM

TH004/16/S

Radiotherapy

Model: syngo RT Therapist 008162815

MHRA reference: 2016/008/005/601/014

Siemens: ADVIA Centaur Systems Calibrator U (Myoglobin) 41733

10 August 2016

IVDs, clinical chemistry

MHRA reference: 2016/008/010/601/005

Terumo:MISAGO® Self-Expanding Stent System

FSCA 1602

Implants, non-active, peripheral vascular stents

Model: Product codes start with SX-V

MHRA reference: 2016/008/004/701/010

bioMérieux: VIDAS TOXO Competition

04 August 2016

IVDs, viral microbiology

MHRA reference: 2016/008/005/299/004

bioMérieux: BK Virus R-gene® Real-time Detection and Quantification Kit

09 August 2016

IVDs, viral microbiology

MHRA reference: 2016/008/010/299/004

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