Field Safety Notice - 20 to 24 November 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 20 to 24 November 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

Accuray Incorporated: TomoTherapy Treatment System

08 November 2017

Radiotherapy

Model: TomoTherapy H Series, TomoTherapy Hi-Art

MHRA reference: 2017/011/023/701/011

Alba Bioscience: ALBAClone Anti-Leb

22 November 2017

IVDs, blood transfusion

Model: Z217

MHRA reference: 2017/011/022/601/014

B Braun: Perfusor Compact Plus

17 November 2017

Infusion systems

Model: Perfusor compact plus; 8717030

MHRA reference: 2017/011/017/601/005

CellaVision: 1. DI-60, 2. CellaVision DM96, 3. CellaVision DM1200, 4. CellaVision DM9600

07 November 2017

IVDs, haematology

Model: N/A

MHRA reference: 2017/011/017/291/030

CEPHEID: MRSA

20 October 2017

IVDs, bacteriology

Model: N/A

MHRA reference: 2017/011/006/701/011

HTL-Strefa S.A

13 November 2017

Insulin injection devices

Model: Microdot droplet pen needle 4mm x 32G 810

MHRA reference: 2017/010/023/291/010

Iris Diagnostics (a Division of Iris International Inc.): iQ200 Series Urine Microscopy Analyzer

21 November 2017

IVDs, clinical chemistry

Model: N/A

MHRA reference: 2017/011/022/601/016

Life Technologies Corporation: Fetal Hemoglobin Monoclonal Antibody (HBF-1)

20 November 2017

IVDs, blood transfusion

Model: MHFH04, MHFH014, MHFH01

MHRA reference: 2017/011/016/601/010

MEDICREA INTERNATIONAL: PASS OCT/ occipital screw driver shaft

20 November 2017

Orthopaedic Surgical instruments - Insertion/extraction tools

Model: A17260020

MHRA reference: 2017/011/022/291/015

Phadia AB: Phadia AB PRIME

QA2017-08

IVDs, immunology

Model: N/A

MHRA reference: 2017/011/022/601/008

Remel Europe Ltd - Thermofisher Scientific: Thermo Scientific™ Remel™ Shigella sonnei (Phases 1&2) Agglutinating Serum

20 November 2017

IVDs, bacteriology

Model: R30164201

MHRA reference: 2017/011/022/601/013

St. Jude Medical (Abbott): Nanostim™ Leadless Pacemaker

17 November 2017

Implants, active, pacemakers

Model: Nanostim™ Leadless Pacemaker S1DLCP

MHRA reference: 2017/011/017/291/010

Teleflex: RUSCH Sensor (Series 400) Silicone

Rectal Pharyngeal Temperature Sensor, Non-Sterile

23 November 2017

Urinary catheters and accessories

MHRA reference: 2017/011/024/228/008

United Orthopedic: U2 Total Knee System Tibial Insert, PS & PSA

17 November 2017

Joint prosthesis, knee

Model: 2303-3032 & 2303-5016

MHRA reference: 2017/011/022/291/012

Vascutek: Anaconda™ Longer Leg Iliac Stent Graft System

30 October 2017

Implants, non active, endoprostheses for aortic aneurysms

Model: N/A

MHRA reference: 2017/011/013/291/001

Volcano (Philips): 400-0100.01

21 November 2017

Ultrasound, imaging

Model

MHRA reference: 2017/011/022/291/017

WallacOy: Specimen Gate Screening Center

16 November 2017

IVD, genetic testing

Model: 5002-0500

MHRA reference: 2017/011/017/291/007

Wassenburg: WASSENBURG WD440, WD440 PT, WD415

15 November 2017

Cssd wash/clean/drying equipment

Model: N/A

MHRA reference: 2017/011/020/701/004

Zimmer

13 August 2017

Dental appliances / instruments

Model: 2220, 2222, 2223, 2224, HLA3G, HLA4G, HLA5G, NEA3G, NEA4G, ZOAT34, ZOAT45, ZOAT56, ZOATKIT, ZOCIMP3A, ZOCIMP3S, ZOCIMP4A, ZOCIMP4S, ZOCIMP5A, ZOCIMP5S, ZOCIMP6A, ZOCIMP6S, ZOCWAX3A, ZOCWAX3S, ZOCWAX4A, ZOCWAX4S, ZOCWAX5A, ZOCWAX5S, ZOCWAX6S, ZOP30A10, ZOP30A11, ZOP30A13, ZOP30S10, ZOP30S11, ZOP30S13

MHRA reference: 2017/011/017/701/025

Zimmer Biomet: TunneLoc Tibial Fixation

17 November 2017

Ligaments, tendons and anchors

Model: N/A

MHRA reference: 2017/011/017/291/018

Published 28 November 2017