Field Safety Notice - 10 to 14 July 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 3 to 7 July 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

Acumed: Acumed Kickstand Post; 2.8mm Locking Drill Guide

27 June 2017

Orthopaedic surgical instruments - Insertion/extraction tools

Model: Kickstand Post: 80-0718; 80-0720; 80-0722; 80-0731

MHRA reference: 2017/007/010/291/030

CellPath: General Histology Instruments

01.139.546 FSCA

IVDs, viral microbiology

MHRA reference: 2017/007/012/291/006

Depuy Synthes: Transpedicular Schanz Screws

6 June 2017

Osteosynthesis, bone screws

Model: Transpedicular Schanz Screws

MHRA reference: 2017/005/025/291/009

Heartway Medical: Minimo Plus 4 S19F

23 June 2017

Scooters, powered

MHRA reference: 2017/006/027/291/003

Hologic: Affirm Lateral Arm Biopsy Accessory Kit

14 July 2017

Surgical instruments, minimal access

Model: ASY-098880

MHRA reference: 2017/007/013/601/001

Leica Biosystems: ASP6025

June 2017

IVDs, cytopathology & histopathology

MHRA reference: 2017/006/012/291/029

Medtronic: Spinous Process Clamp Tall and Short (Model 9734715 and 9734716), Double Spinous Process Clamp Tall and Short (Model9734723 and 9734724)

11 July 2017

Surgical instruments, articulated holding

Model: 9734715, 9734716, 9734723, 9734724

MHRA reference: 2017/007/011/291/025

Pulsar Vascular: PulseRider®

11 July 2017

Implants, non-active, embolisation

MHRA reference: 2017/007/003/701/001

Siemens: ADVIA Chemistry Assays, Dimension Assays, Dimension Vista Assays, Syva Assays

June 2017

IVDs, clinical chemistry

MHRA reference: 2017/007/013/601/003

SHIMADZU Corporation: RADspeed Series (Pro/CH-200/CH-200M)

26 May 2017

X Ray, general

MHRA reference: 2017/006/029/701/007

Published 17 July 2017