Field Safety Notice - 10 - 14 December 2018

List of field safety notices (FSNs) from medical device manufacturers from 10 - 14 December 2018

• From: Medicines and Healthcare products Regulatory Agency
• Published: 18 December 2018
• Last updated: 20 December 2018 — See all updates

• Message type: Field safety notice
• Medical specialty: Anaesthetics, Cardiology, Care home staff, Cosmetic surgery and Critical care
  Show 17 more
  Dentistry, General practice, General surgery, Haematology and oncology, Infection prevention, Obstetrics and gynaecology, Ophthalmology, Orthopaedics, Paediatrics, Pathology, Pharmacy, Physiotherapy and occupational therapy, Radiology, Renal medicine, Theatre practitioners, Urology, and Vascular and cardiac surgery
• Issued: 18 December 2018

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

Acutronic: fabian

07 December 2018

Lung ventilators

Model: abian HFO/fabian +nCPAP evolution/ fabian Therapy evolution

MHRA reference: 2018/012/010/291/006

Allergan: Allergan Breast Implants and Tissue Expanders

FSCA-18-001

Implants, breast

MHRA reference: 2018/012/019/291/006

Diffuplast srl: ExactaMix

22 November 2018

Feeding systems and tubes

MHRA reference: 2018/012/006/487/017

Drager: Jaundice Meter

November 2018

Diagnostic measurement and monitoring

Model: JM-105

MHRA reference:2018/004/017/291/014

###Elekta: MOSAI

Q and Sequencer

December 2018

Radiotherapy

MHRA reference: 2018/012/012/487/002

Ethicon

PROXIMATE® Hemorrhoidal Circular Stapler

Staples and staple guns

MHRA reference: 2018/012/006/701/024

GE: CARESCAPE B850

FMI 36135

Monitors, patient

MHRA reference: 2018/012/010/291/003

GE: Discovery NM 530c, Ventri

FMI 40880

Nuclear medicine

MHRA reference: 2018/012/012/291/001

Hitachi (Roche): cobas 8100 system

07 December 2018

IVDs, clinical chemistry

Model: 07123841001 / 07123850001

MHRA reference: 2018/012/012/291/004

Hologic: I-View Contrast Enhanced Digital Mammography

FA-00056

Mammography

MHRA reference: 2018/012/010/601/008

Ion Beam Applications: Proteus 235

10 December 2018

Radiotherapy

MHRA reference: 2018/012/010/487/018

Peters Surgical: Trocar ENDOSPHERE

07 June 2018

Surgical instruments, minimal access

MHRA reference: 2018/012/010/291/001

Roche: Accu-Chek® Insight

December 2018

Infusion systems

Model: 00700006889

MHRA reference: 2018/011/028/701/019

Schuchmann: Malte, Malte-Outdoor, MArcy; 7502000,7502100,

7503000, 7504000, 7503100, 7602000,7603000, 7602100, 7603100 /

18 April 2018

Walking aids, walking frames

MHRA reference: 2018/005/022/478/002

Siemens: Atellica IM Analyzer: Anti-Thyroglobulin (aTG) ; ADVIA Centaur/XP/XPT and ADVIA Centaur CP anti-Tg (aTG

December 2018

IVDs, clinical chemistry

MHRA reference: 2018/012/012/601/001

Terumo: Trima Accel Automated Blood Collection System

December 2018

Apheresis

MHRA reference: 2018/012/010/291/004

Vertex: Vertex Castavaria

05 December 2018

Dental materials

MHRA reference:2018/012/010/291/002

Published 18 December 2018
Last updated 20 December 2018 + show all updates

1. 20 December 2018

   Added entry for Allergan Breast Implants and Tissue Expanders.

2. 18 December 2018

   First published.