Field Safety Notice - 18 to 22 December 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 December 2017

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

Abbott: ARCHITECT DHEAS-S Reagent Kit

14 December 2017

IVDs, clinical chemistry

Model: 8K27-20; 8K27-25

MHRA reference: 2017/012/019/071/002

Arkray Factory

08 December 2017

IVDs, self / home testing

Model: SPOTCHEM II

MHRA reference: 2017/012/018/291/006

BIOMERIEUX: ETEST®TP 256 (TEICOPLANIN)

15 December 2017

IVDs, bacteriology

MHRA reference: 2017/012/021/291/001

Biomet Orthopedics

18 December 2017

Bone cement and tools

Model: OPTIPAC 40 REFOBACIN

MHRA reference: 2017/012/019/071/001

Boston Scientific: VALITUDE™, VISIONIST™ CRT-P and CHARISMA™, MOMENTUM™, RESONATE™, VIGILANT™, AUTOGEN™, DYNAGEN™, INOGEN™, ORIGEN™ CRT-D

December 2017

Implants, active, pacemakers

MHRA reference: 2017/012/019/291/018

Boston Scientific: ACCOLADE, ALTRUA 2, ESSENTIO, PROPONENT, VALITUDE, VISIONIST

December 2017

Implants, active, pacemakers

MHRA reference: 2017/012/019/291/016

Boston Scientific Corporation: Uro / Pelvic Health:

Malecot Nephrostomy Catheter Set Re-Entry™ Malecot Nephrostomy Catheter Set Percutaneous Access Set Peripheral Intervention: Malecot Nephrostomy Catheter System

14 December 2017

Urinary catheters and accessories

Model: Uro/Pelvic Health:

Malecot Nephrostomy Catheter Set M0064101000 M0064101010

Re-Entry Malecot Nephrostomy Catheter Set M0064101040 M0064101050

Percutaneous Access Set M0064201150

Peripheral Intervention Malecot Nephrostomy Catheter System M001224110

MHRA reference: 2017/012/018/291/017

CareFusion: Vyntus BODY with Option Diffusion

30 November 2017

Therapy tissue ablation

MHRA reference: 2017/012/019/228/007

Cepheid: Xpert® GBS

07 December 2017

IVDs, bacteriology

MHRA reference: 2017/012/020/291/028

Cepheid: 17FAR013 HIV-1 VL Cepheid FSCA ANSM Ref R1720294

6 December 2017

IVDs, viral microbiology

MHRA reference: 2017/012/018/131/001

Cook Medical: Norm-Ject Tuberkulin Syringe

19 December 2017

Laboratory equipment associated with IVF, cells, tissues

Model: Norm-Ject Tuberkulin Syringe

MHRA reference: 2017/012/020/291/002

Cousin Biotech: NAJA

20 December 2017

Spinal implants

Model: RCBNAJ55LU, RCBNAJ55RU

MHRA reference: 2017/012/020/291/033

Covidien

12 December 2017

Lung ventilators

Model: Puritan Bennett 980 Ventilator & PB980 Rechargeable Lithium Ion Battery

MHRA reference: 2017/012/018/228/020

Covidien (Medtronic): Signia Power Handle

December 2017

Staples and staple guns

MHRA reference: 2017/012/020/291/029

DePuy Spine: Confidence Spinal Cement System

December 2017

Bone cement and tools

Model: 283910000; 283913000

MHRA reference: 2017/012/019/291/019

Depuy Synthes: GLOBAL® UNITE® Platform Shoulder System

December 2017 Joint prosthesis, shoulder

MHRA reference: 2017/012/018/701/021

Establishment Labs: Motiva Implants

18 December 2017

Implants, breast

Model: ERSF-255Q

MHRA reference: 2017/007/029/601/001

Greiner Bio-One: VACUETTE FC MIX Tube

20 December 2017

IVDs, specimen receptacles

Model: 454510, 454511, 454513, 454514

MHRA reference: 2017/012/020/228/003

Konica Minolta

13 December 2017

Ultrasound, imaging

Model: Sonimage HS1

MHRA reference: 2017/012/019/228/005

MAKO Surgical Corp: MCK TIBIAL BASEPLATE-RM/LL-SZ 2 & 7

December 2017

Joint prosthesis, knee

MHRA reference: 2017/012/020/291/001

Medtronic Sofamor Danek: KYPHON® Express Directional Bone Filler

December 2017

Bone cement and tools

Model: F06B

MHRA reference: 2017/012/019/228/004

Monica Healthcare (GE): Monica Novii Wireless Patch System, Monica IF24

December 2017

Monitors, foetal

MHRA reference: 2017/012/019/131/001

Nobel Biocare: IPS CaseDesigner

07 December 2017

X ray, dental imaging

MHRA reference: 2017/012/013/228/022

Physio-Control

December 2017

Defibrillators, non implantable

Model: 3202380-006

MHRA reference: 2017/012/014/228/011

Roche: Elecsys BRAHMS PCT

14 December 2017

IVDs, clinical chemistry

MHRA reference: 2017/012/019/291/014

Siemens Healthcare Diagnostic Products Limited: Various analytes

13 December 2017

IVDs, clinical chemistry

MHRA reference: 2017/012/015/601/010

Siemens: ADVIA Centaur

December 2017

IVDs, clinical chemistry

Model: ADVIA Centaur CP, ADVIA Centaur XP, ADVIA Centaur XPT

MHRA reference: 2017/012/021/601/003

Smith & Nephew Orthopaedics: Taylor Spatial Frame Website Software

13 December 2017

Osteosynthesis, external fixators

MHRA reference: 2017/012/019/071/003

Spectranetics: 0.9 mm X-80 VITESSE RX CATHETER

14 December 2017

Vascular cannula and catheters

Model: 110-004

MHRA reference: 2016/012/014/701/005

TRUMPF: TruVidia™ Wireless Receiver

December 2017

Lamps & lights

MHRA reference: 2017/012/018/228/024

WallacOy: LifeCycle for Prenatal Screening

14 December 2017

IVD, genetic testing

Model: 5015-0020

MHRA reference: 2017/012/020/228/004

Zimmer: Various Hip and Knee products

15 December 2017

Joint prosthesis, knee

MHRA reference: 2017/012/019/131/002

Zimmer Biomet: Persona Partial Knee Spacer Blocks

12 December 2017

Joint prosthesis, knee

Model: Persona Partial Knee Spacer Blocks

MHRA reference: 2017/012/018/701/036

Zimmer GmbH: MODULAR RASP DISTAL CURVED REVITAN RASP DISTAL CUR

15 December 2017

Joint prosthesis, hip

MHRA reference: 2017/012/019/131/003

Published 27 December 2017