Field Safety Notice - 11 to 15 June 2018

Summary List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 June 2018.


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 (St Jude Medical Inc.): CardioMems Hospital and Patient Electronic System

14 June 2018

Implants, active, monitors and recorders

Model: CM3000, CM1100

MHRA reference: 2018/006/013/291/001


7 June 2018


MHRA reference: 2018/006/008/601/003

Bard: Arctic Sun® Temperature Management System


Heating, patient, electrical pads & blankets

MHRA reference: 2018/006/011/601/003

Becton Dickinson: BD Vacutainer® Urine Collection Cup

4 June 2018

IVDs, specimen receptacles

MHRA reference: 2018/005/023/291/008

Becton Dickinson: BD FACS™ Universal Loader

8 June 2018

IVDs, haematology

MHRA reference: 2018/006/013/291/016

BioFire Diagnostics: FilmArray Blood Culture Identification (BCID) Pan

June 2018

IVDs, bacteriology

MHRA reference: 2018/003/026/701/019

Cardinal Health: Hydroline Trumpet Valve

11 June 2018

Surgical equipment, miscellaneous

MHRA reference: 2018/006/011/601/014

Dialab: CK-MB, opt. DGKC / IFCC; GLDH, DGKC

7 June 2018

IVDs, clinical chemistry

MHRA reference: 2018/006/014/701/007

Grifols: MDmulticard® Basic Extended Phenotype

13 June 2018

IVDs, blood transfusion

MHRA reference: 2018/006/013/701008

Guangzhou Sunray Medical Apparatus: SRF618X9 B Maternal and Fetal Monitor

13 April 2018

Monitors, foetal

MHRA reference: 2018/006/011/291/009

Medtronic: Single Chamber Temporary Pacemaker

June 2018

Pacemakers, external

Model: 53401

MHRA reference: 2018/006/011/291/019

Ortho-Clinical: VITROS Chemistry Products Na+ Slides

June 2018

IVDs, clinical chemistry

MHRA reference: 2018/006/011/601/007

Randox Laboratories: Liquid Assayed Specific Protein Controls

03 May 2018

IVDs, clinical chemistry

Model: PS2682, PS2683, PS2684

MHRA reference: 2018/005/008/601/005

Randox: Liquid Cardiac Control

05 June 2018

IVDs, clinical chemistry

Model: CQ5053

MHRA reference: 2018/006/008/601/009

RaySearch Laboratories: RayStation

5 June 2018

Radiotherapy planning and verification systems

Model: RayStation 2.5, RayStation 3.5, RayStation 4.0, RayStation 4.3, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2) and RayStation 7 (RayPlan 7)

MHRA reference: 2018/006/011/701/006

Sirona Dental Systems (Dentsply): CEREC AC Connect

15 April 2018

Intense pulse light Source

MHRA reference: 2018/006/011/478/003

Terumo: Terumo® Hypodermic NEOLUS Needle

June 2018

Injection devices

Model: NN-2516R04T, NN-2525R, NN-2116R, NN-2125R, NN-2316R, NN-2325R04T, NN-2516R

MHRA reference: 2018/006/012/081/003

Thermo Fisher Scientific: Oxoid

19 May 2018

IVDs, bacteriology

Model: CT0159B

MHRA reference: 2018/004/024/601/004

Published 20 June 2018