Field Safety Notice - 15 October to 19 October

List of field safety notices (FSNs) from medical device manufacturers from 15 October to 19 October

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 Alinity hs Slide Maker Stainer Module

11 October 2018

IVDs, haematology MHRA reference: 2018/010/016/487/012

Abbott: Alinity Free T3 Reagent Kit and Alinity Total T3 Reagent Kit

12 October 2018

IVDs, clinical chemistry

MHRA reference: 2018/010/016/487/009

Abbott (Architect): ARCHITECT Free T3 Reagent Kit and ARCHITECT Total T3 Reagent Kit

12 October 2018

IVDs, clinical chemistry

MHRA reference: 2018/010/016/487/010

Abbott (Architect): ARCHITECT HAVAb-IgG;-IgM; Alinity i HAVAB IgG

17 October 2018

VDs, Viral Microbiology

MHRA reference: 2018/010/018/291/010

Alba Bioscience (Quotient): ALBAcyte® RhD Negative CAT Reagent Red Cells for Antibody Screening

15 October 2018

IVDs, blood transfusion

Model: Z466

MHRA reference: 2018/010/016/601/003

Biomet (Zimmer Biomet): Mallory-Head Acetabular Shell

18 October 2018

Joint Prosthesis, Hip

MHRA reference: 2018/010/018/291/007

Biomet (Zimmer Biomet): Rapid Flap SpinDown Clamp

16 October 2018

Osteosynthesis, Bone Plates

MHRA reference: 2018/010/016/487/014

Covidien (Medtronic): Parietex™ Composite Parastomal Mesh

October 2018

Surgical mesh for hernia repair.

MHRA reference: 2018/010/015/291/018

Depuy Synthes: CORAIL® Female Broaches

15 October 2018

Surgical instruments, non articulated cutting

MHRA reference: 2018/010/015/291/026

Endologix: Nellix, Endovascular Aneurysm Sealing System

15 October 2018

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-004; NP-001; NP-003; NP-005; NX-001, NX-002a

MHRA reference: 2018/010/015/601/003

GE Healthcare: CARESCAPE Monitor B450, B650, B850

FMI 36127A

Monitors, patient

MHRA reference: 2018/010/017/291/003

Illumina: VeriSeq NIPT Solution

16 October 2018

IVD, genetic testing

Model: 15076164

MHRA reference: 2018/010/015/601/002

Immucor: Pak LxTM Assay

06 January 2017

IVDs, clinical chemistry

MHRA reference: 2018/010/017/291/011

Maquet (Getinge): QUDROX-i Neonatal Microporous Membrane Oxygenator

11 October 2018

Infusion & transfusion, heart lung circuits

Model: 70104.8599; 70104.8600; 70104.6979; 70104.7003

MHRA reference: 2018/010/015/291/013

October 2018

Implants, active, pacemakers

Model: 2090, 29901

MHRA reference: 2018/010/012/291/013

Medtronic (FA846): O-armTM O2 Imaging System

October 2018

X Ray, fluoroscopy systems

Model: BI70002000, BI70002000R

MHRA reference: 2018/010/015/291/021

Randox (RX3485): Evidence Operators Manual

12 October 2018

IVDs, clinical chemistry Model: RX3485

MHRA reference: 2018/010/012/601/006

Randox (RX5000): Brand

12 October 2018

IVDs, clinical chemistry

Model: RX5000

MHRA reference: 2018/010/012/601/003

SPINEART: FSCA-02-2018

08 October 2018

Spinal implants

Model: PAD-IM WT 12-S

MHRA reference: 2018/010/012/487/004

St. Jude Medical (Abbott): St. Jude Medical Infinity™ DBS System (8-Channel)

11 October 2018

Implants, active, stimulators, neuro

MHRA reference: 2018/010/011/291/003

Stephanix: SP4S, SP4S option AT, SP4S option AP

08 October 2018

X Ray, digital acquisition systems

MHRA reference: 2018/010/012/291/002

Published 22 October 2018