Field safety notices - 28 May to 1 June 2018

Summary List of field safety notices (FSNs) from medical device manufacturers from 28 May to 1 June 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

Abbott (Thoratec Corporation): HeartMate 3™ Left Ventricular Assist System – Updated FSN

25 May 2018

Implantable ventricular assist devices

Model: 106524INT HM3 LVAS Kit

MHRA reference: 2018/004/009/291/032

Arrow International (Teleflex Medical): VPS Rhythm™ ECG Accessory Pack with Johans Adapter

VPS Rhythm™ ECG Accessory Pack VPS TipTracker™ Stylet Accessory Peripherally Inserted Midline Catheter Kit with Placement Wire

24 May 2018

Vascular cannula and catheters

MHRA reference: 2018/005/025/478/011

Berlin Heart: Ventricular

28 May 2018

Implantable ventricular assist devices

Model: P10P-001, P15P-001, P25P-001x01, P30P-001x01, P50P-001, P60P-001

MHRA reference: 2018/005/028/601/002

DiaSys: Tests based on NAD(H) and/or NADP(H) reaction

28 May 2018

IVDs, clinical chemistry

MHRA reference: 2018/005/030/701/012

Draeger: Fabius, Apollo, Perseus A500

May 2018

Anaesthetic machines & monitors

MHRA reference: 2018/005/021/478/002

Heraeus: PALACOS® and COPAL® bone cements Brand

19 July 2017

Bone cement and tools

MHRA reference: 2018/005/030/291/009

Implant Direct: RePlant Angled Abutment 6050-52-60

May 2018

Implants, dental

MHRA reference: 2018/005/016/601/006

INEX SILICONE (SEBBIN): INEX SILICONE Devices

09 February 2018

Surgical instruments, minimal access

Model: Medical devices for lipofilling

MHRA reference: 2018/005/031/291/009

MAKO Surgical(Stryker): RIO system Irrigation Clip

May 2018

Surgical equipment, miscellaneous

MHRA reference: 2018/005/025/291/019

Megadyne: MegaPower Electrosurgical Generator

May 2018

Surgical, diathermy

MHRA reference: 2018/005/030/701/005

Microport CRM (former Livanova): PLATINIUM VR – Updated Cover Letter

15 May 2018

Implants, active, defibrillators

Model: VR 1240, DR 1540, CRT-D 1741, SonR CRT-D 1841, 4LV CRT-D 1744, 4LV SonR CRT-D 1844

MHRA reference: 2018/003/019/291/005

Millipore Ltd

May 2018

IVDs, clinical chemistry

Model: Minicon B-15, Minicon CS-15

MHRA reference: 2018/005/030/478/017

Newdeal SAS (INTEGRA): ADVANSYS MLP/DLP; ADVANSYS TTC; TIBIAXYS; UNI-CP;

17 May 2018

Osteosynthesis, bone screws

Model: 330021S; 330023S; 330025S; 30030S; 330217S; 330220S;

MHRA reference: 2018/005/025/291/009

Nursing Hygiene Group: Steiss

27 September 2018

Hoists and slings

Model: Hoist Activate 18

MHRA reference: 2017/011/029/601/006

Roche: IGG-2 (Tina-quant IgG Gen.2)

May 2018

IVDs, clinical chemistry

MHRA reference: 2018/005/030/701/029

Siemens: Biograph mCT and Biograph mCT Flow

MI516/16/S + MI513/17/S

Nuclear medicine, gamma camera systems & accessories

Model: 10248668, 10248669, 10248670, 10248671, 10248672

MHRA reference: 2018/005/030/601/005

Stanmore Implants: General Impactor

23 May 2018

Orthopaedic surgical instruments - impacting tools

Model: General Impactor imgenimp

MHRA reference: 2018/005/024/478/015

Wassenburg Medical: WASSENBURG endoscope

07 May 2018

Cssd wash/clean/drying equipment

Model: WD440, WD440 PT, WD415

MHRA reference: 2018/005/009/228/001

Published 4 June 2018