Field Safety Notices - 22 - 26 May 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 22 - 26 May 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

Applied Medical: Kii Shielded Bladed Z-Thread Dual Pack

18 May 2017

Surgical instruments, minimal access

Model: CTB14, CTB23

MHRA reference: 2017/005/022/291/006

B&D Electromedical: NIPPY 3+ RANGE OF VENTILATORS

11 May 2017

Lung ventilators

MHRA reference: 2017/005/023/291/017

CareFusion: Brand

February 2017

Infusion systems

Model: 8000 and 8015

MHRA reference: 2017/005/025/291/035

Christoph Miethke: Shuntassistant

27 April 2017

Implants, non active, hydrocephalus

Model: FV253T

MHRA reference: 2017/005/019/291/011

Cook: See Comments Section

27 April 2017

Surgical devices, non-powered

MHRA reference: 2017/005/019/701/006

Dale Medical Products: 270/273 Endotracheal Tube Holders

25 April 2017

Airway devices

Model: H84102701 and H84102731

MHRA reference: 2017/005/015/291/003

DePuy Orthopaedics: PINNACLE® Hip Sector DUOFIX® HA Shell 58MM

Feb 2017

Joint prosthesis, hip

MHRA reference: 2017/005/023/299/001

GE OEC Medical Systems: OEC Elite

FMI 15137

X Ray, fluoroscopy systems

MHRA reference: 2017/005/025/291/031

GE Healthcare Medical Systems

5 May 2017

Monitors, Patient

Model: Dash 4000

MHRA reference: 2016/011/018/401/012

Leica Microsystems: Leica M525 F40

05 May 2017

Surgical equipment, miscellaneous

MHRA reference: 2017/005/019/291/019

Philips Medical Systems: DigitalDiagnost

18 April 2107

X Ray, digital acquisition systems

Model: 712026

MHRA reference: 2017/005/019/291/006

Philips Healthcare: IntelliVue NMT Patient Cable

26 April 2017

Monitors, patient

Model: Philips IntelliVue NMT Patient Cables (989803174581)

MHRA reference: 2017/005/019/291/010

Medos International: LATARJET EXPERIENCE

18 May 2017

Orthopaedic surgical instruments - Insertion/extraction tools

Model: 288211, 288201, 288202, 288203, 288216

MHRA reference: 2017/005/023/291/027

Medtronic MiniMed: MiniMed 640G Insulin Pump, MMT-1711, MMT-1712

May 2017

Infusion systems

MHRA reference: 2017/005/025/291/023

Molnlycke: Brennen® Skin Graft Mesher

17 May 2017

Surgical power tools

MHRA reference: 2017/005/023/291/024

Mölnlycke Health Care: See attached Product Table

23 May 2017

Sutures

MHRA reference: 2017/005/023/701/015

Nutricia Medical Devices: Flocare Gastrostomy tube (G-tube) - ENFit

24 May 2017

Feeding systems and tubes

Model: Ch10, Ch14, CH16, Ch18, Ch20

MHRA reference: 2017/005/022/291/021

Roche: cobas p 512 pre-analytical system (model number: 07563124001)

cobas p612 pre-analytical system (model number: 07563116001)

16 May 2017

IVDs, clinical chemistry

MHRA reference: 2017/005/019/701/020

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS: Beneview T1 Patient Monitor

March 2017

Monitors, patient

MHRA reference: 2017/004/020/701/007

St Jude Medical:Nanostim™ Leadless Pacemaker

FA2017-05

Implants, active, pacemakers

Model: LSP102

MHRA reference: 2017/005/011/701/022

Stryker Instruments-Kalamazoo: Stryker SmartLife Large Aseptic Housings

March 2017

Surgical power tools

Model: 7126-120-000

MHRA reference: 2017/003/020/291/020

Zimmer Biomet: Vitality Spinal Fixation System

24 May 2017

Orthopaedic surgical instruments - insertion/extraction tools

MHRA reference: 2017/005/025/701/004

Published 31 May 2017