Field safety notices - 09 to 13 July

Summary List of field safety notices (FSNs) from medical device manufacturers from 09 June to 13 July 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

BIOMERIEUX: BacT/ALERT VIRTUO Microbial Detection System

5 July 2018

IVDs, bacteriology

MHRA reference: 2018/007/005/291/041

Biomet (Zimmer Biomet): Persona® Spacer Block Alignment Tower

12 July 2018

Orthopaedic surgical instruments - insertion/extraction tools

MHRA reference: 2018/007/012/291/025

Cerner Corporation: Cerner Dosage Calculator

29 June 2018

Diagnostic / therapeutic software algorithm

MHRA reference: 2018/007/009/601/008

Convatec: AbViser AutoValve Pressure Monitoring Devic

25 April 2018

Urinary catheters and accessories

Model: ABV300; ABV301

MHRA reference: 2018/004/011/478/008

Cook Medical: Chorion Villus Biopsy Needle Set K-CVNS-1821-ROBINSON-ET

28 June 2018

Surgical instruments, minimal access

MHRA reference: 2018/007/006/701/005

DePuy Synthes: CORAIL® Cementless Femoral Stem HA coated

22 June 2018

Joint prosthesis, hip

Model: 3L92511, 3L92512

MHRA reference: 2018/007/012/291/006

DXC: iLab

5 July 2018

IVDs, clinical chemistry

Model: versions earlier than i.LAB TP AKI 2.0 Build 3_ER01

MHRA reference: 2018/007/006/601/003

EBR Systems: first generation WiSE CRT Model 4000 Transmitter

21 June 2018

Implants, active, pacemakers

MHRA reference: 2018/006/020/081/009

Etac: Molift 2-poing Sling Bar - all sizes

4 July 2018

Hoists and slings

Model: 1430016, 1430017, 1430021, 1830001, 183002, 183002C, 1830003

MHRA reference: 2018/007/006/701/009

Fritz Stephan: Sophie

01 June 2018

Lung ventilators

MHRA reference: 2018/007/012/291/001

GE Healthcare: Carescape Monitor B650

GEHC ref 36127

Monitors, patient

MHRA reference: 2018/007/003/291/031

Luminex: Brand

06 July 2018

IVDs, bacteriology

Model: JDK-2330 Rev B

MHRA reference: 2018/007/010/291/016

Megadyne (Update): MegaPower Electrosurgical Generator

July 2018

Surgical, diathermy

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

Menarini Silicon Biosystems: CellSearch Circulating Tumor Cell Kit

12 April 2018

IVDs, cytopathology & histopathology

MHRA reference:2018/007/010/291/023

NordicNeuroLab: LCD Power Supply (LPS)

CPA-2018-473

Magnetic resonance, equipment & accessories

MHRA reference: 2018/007/009/291/033

Ortho Solutions: K-Wire

4 July 2018

Osteosynthesis, skeletal pins, wires & staples

Model: OS21675 & OS292120

MHRA reference: 2018/007/009/601/003

Philips: Brilliance 16 Air Brilliance 64 Brilliance iCT

3 July 2018

Computed tomography

Model: Brilliance 16 Air - 728246 Brilliance 64 – 728231 iCT – 728306

MHRA reference: 2018/007/010/291/015

Randox Laboratories: LIA3148 Custom Liquid Immunoassay Control Level 1

4 July 2018

IVDs, clinical chemistry

MHRA reference: 2018/007/005/601/003

Roche: Vitamin D total II assay

9 July 2018

IVDs, clinical chemistry

Model: Vitamin D total II assay on Elecsys and cobas e immunoassay analyzers

MHRA reference: 2018/004/018/701/015

Teleflex: Rusch Green Lite (MAC 3)

9 July 2018

Airway devices

MHRA reference: 2018/007/010/291/022

Updates to this page

Published 16 July 2018