Field Safety Notice - 9 to 13 October 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 October 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

Abbott:Alinity hq Analyzer

5 October 2017

IVDs, haematology

MHRA reference: 2017/010/012/291/010

Agilent: FLEX Monoclonal Rabbit Anti-Human Estrogen Recepto

5 October 2017

IVDs, cytopathology & histopathology

MHRA reference: 2017/010/009/701/030

Alba Bioscience: ALBAcyte

09 October 2017

IVDs, blood transfusion

Model: ALBAcyte Reagent Red Cells for Antibody Identification (Papainised)

MHRA reference: 2017/010/009/601/001

Beckman Coulter: AQUIOS CL Flow Cytometer System

09 October 2017

IVDs, haematology

MHRA reference: 2017/010/009/601/003

Biomet: Vanguard CR Tibial Bearing

09 October 2017

Joint prosthesis, knee

MHRA reference: 2017/010/010/701/022

CareFusion: Alaris™/ Asena™ GS, GH, CC, TIVA, PK, Syringe Pumps

September 2017

Infusion systems

Model: all variants with prefix 8001, 8002, 8003, 8004, and 8005 (pumps manufactured before September 2008 only)

MHRA reference: 2017/010/003/701/009

Endologix: Nellix, Endovascular Aneurysm Sealing System

06 October 2017

Implants, non active, endoprostheses for aortic aneurysms

Model: N10-100, N10-110, N10-120, N10-130, N10-140, N10-150,N10-160, N10-170, N10-180, N10-190, N10-200, NP-002; NP-001; NP-003; NP-005; NX-001, NX-002a

MHRA reference: 2017/010/006/601/002

LINET: Multicare

18 August 2017

Beds and accessories

Model: Multicare 1MC

MHRA reference: 2017/010/009/291/024

Medacta International SA

29 September 2017

Joint prosthesis, knee

Model: GMK Sphere & GMK Primary PS Inserts – all codes

MHRA reference: 2017/010/005/701/007

Medtronic: CareLinkTM iProTM Therapy Management Software (component of iPro Continuous Glucose Monitoring System)

October 2017

Continuous glucose monitoring systems (CGMS)

Model: MMT-7340

MHRA reference: 2017/010/012/291/053

Medtronic:FlexCath Advance™ Steerable Sheath

October 2017

Vascular cannula/catheter accessories

Model: 4FC12

MHRA reference: 2017/010/012/291/041

NordicNeuroLab: AudioSystem-Headphone Slim

28 September 2017

Stimulators diagnostic

MHRA reference: 2017/010/005/291/018

Otto Bock: Voyager Evo rigid frame wheelchair

4 October 2017

Wheelchairs, manual

Model: 480A76=00000_K

MHRA reference: 2017/010/012/291/040

Philips

September 2017

Monitors, patient

Model: Cisco ASA 5506-X Network Firewall. 867098

MHRA reference: 2017/010/009/291/022

Radiometer: TCM5 FLEX/TCM5 BASIC

FAN 915-375

Diagnostic measurement and monitoring

MHRA reference: 2017/010/012/291/008

Randox Laboratories: Liquid Cardiac Control

17 February 2017

IVDs, clinical chemistry

Model: CQ5051, CQ5052 & CQ5053

MHRA reference: 2016/009/016/601/009

Schaerer Medical AG: schaerer arcus

26 September 2017

Operating table

MHRA reference: 2017/004/003/299/001

Stryker: Various Stryker Hip Products

26 September 2017

Joint prosthesis, hip

MHRA reference: 2017/010/011/291/016

Stryker: TACTYS - IPP prosthesis - Distal Stem Size S and M

October 2017

Joint prosthesis, hip

MHRA reference: 2017/010/006/701/013

Teleflex: AUTO ENDO05 ML

12 October 2017

Clip appliers

MHRA reference: 2017/010/012/291/044

Tracoe medical: TRACOE twist

11 October 2017

Airway devices

Model: REF 301-06, REF 302-06, REF 303-06, REF 304-06, REF 306-06

MHRA reference: 2017/010/012/291/043

Trans Medics: OCS Heart

2 October 2017

Storage & collection devices

Model: OCS Heart; 1200

MHRA reference: 2017/010/002/601/007

Vascutek: Anaconda™ ONE-LOK™ AAA Stent Graft System

28 September 2017

Implants, non active, endoprostheses for aortic aneurysms

MHRA reference: 2017/009/027/701/023

Zimmer: Pulsavac Plus

27 September 2017

Surgical equipment, miscellaneous

MHRA reference: 2017/010/010/701/005

Rochester Medical

FA2017-51

Urinary catheters and accessories

Model: HYDROSIL Gripper, Personal and Magic3 Intermittent; NA

MHRA reference: 2017/010/006/701/009

Published 23 October 2017
Last updated 24 October 2017 + show all updates
  1. Included Rochester
  2. First published.