Field Safety Notice - 27 to 29 December 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 27 to 29 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

Aesculap: DS-SINGLE FIRE LIG. CLIPS

13 December 2017

Clip appliers

Model: DS Titanium Ligation-Clips

MHRA reference: 2017/012/022/291/001

Boston Scientific: SpyScope™ DS Access and Delivery Catheter

December 2017

Endoscopes, flexible

MHRA reference: 2017/012/022/291/003

Depuy Synthes: SIGMA® HP PFJ Cemented Trochlear Implants.

December 2017

Joint prosthesis, knee

Model: 102403100,102403200,102403300,102403400, 102403500

MHRA reference: 2017/012/028/291/003

Establishment Labs: Motiva Implants

21 December 2017

Implants, breast

MHRA reference: 2017/012/022/291/006

GE: Carescape R860

December 2017

Lung ventilators

Model: Carescape R860; GTIN # 00840682102346

MHRA reference: 2017/012/0 22/291/015

Medtronic: Medtronic Clip Gun™ Scalp Clip System

December 2017

Clip appliers

Model: CG8900, CG8901 and CG8901A

MHRA reference: 2017/012/022/291/002

Merit Medical: Prelude SNAP™ Splittable Sheath Introducer

Prelude SNAP recall

Vascular cannula and catheters

MHRA reference: 2017/012/022/291/005

Roche: Cobas u 601 urine analyzer, Model No. 06390498001

cobas u 701 microscopy analyzer, Model No. 06390501001

21 December 2017

IVDs, clinical chemistry

Model: Cobas u 601 urine analyser

MHRA reference: 2017/012/022/291/007

Siemens: All artis systems with Wireless foot switch

18 September 2017

X ray, fluoroscopy systems

MHRA reference: 2017/012/022/601/007

Siemens: Artis systems

5 December 2017

X ray, fluoroscopy systems

Model: ARTIS Systems operated with ARTIS tables

MHRA reference: 2017/012/022/601/005

Stanmore: Custom Implants with MIG component

21 December 2017

Joint prosthesis, knee

MHRA reference: 2017/012/022/291/020

Roche (Ventana): OptiView DAB IHC Detection Kit, ultraView Universal DAB Detection Kit, iView DAB Detection Kit, ultraView SISH Detection Kit, CINtec PLUS Cytology Kit (CE-IVD), OptiView Amplification Kit, Hematoxylin II

25 January 2018

Instrumentation/platform

Model: OptiView DAB IHC Detection Kit,

MHRA reference: 2017/012/022/291/012

Published 2 January 2018