Field Safety Notice - 19 to 23 March 2018

Summary List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 March 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

Acutronic: fabian Therapy evolution

19 March 2018

Lung ventilators

Model: 121001

MHRA reference: 2018/003/021/291/001

Bentley InnoMed: BeGraft Peripheral Stent Graft System

19 March 2018

Implants, non active, peripheral vascular stents

MHRA reference: 2018/003/021/291/004

Caesarea Medical Electronics:100-100SM T34 Ambulatory Syringe Pump

07 March 2018

Infusion systems

MHRA reference: 2018/002/026/291/004

Cook Medical: StoneBreaker Pneumatic Lithotripter

07 March 2018

Lithotripsy, external and internal

MHRA reference: 2018/003/021/478/020

Covidien (CardinalHealth): Yankauer Suction Tubing Penrose Tubing Trocar Catheter Thoracic Catheter

19 March 2018

Suction equipment

MHRA reference: 2018/003/021/291/002

GE Vingmed Ultrasound AS:TEE Probes


Ultrasound, imaging

MHRA reference: 2018/003/019/291/006

Implant Direct Sybron Manufacturing LLC: simply InterActive® Implant

March 2018

Implants, Dental

Model: 655010U

MHRA reference: 2018/003/015/601/016

Intuitive Surgical: da Vinci X Surgical System


Endoscopes, rigid

MHRA reference: 2018/003/016/701/013

Kimal: Altius Central Venous Catheter Kit

March 2018

Vascular cannula and catheters

MHRA reference: 2018/003/021/291/020

Macopharma: Easyflex PVC

19 March 2018

Infusion & transfusion, administration sets

MHRA reference: 2018/003/021/291/003

Micronclean LTD: MicronDevices Sterile Packs

21 March 2018

Injection devices

MHRA reference: 2018/003/022/291/002

Polymer Technology Systems Diagnostics: PTS Panels CHOL+GLU Test Panel Test Strips

13 March 2018

Instrumentation/ platform

MHRA reference: 2018/003/021/478/013

Siemens Healthcare: Primus, Oncor



Model: 01940035, 04504200, 05857912, 05857920, 05863472,

MHRA reference: 2018/003/009/601/008

Siemens: Syva Emit II Plus 6-Acetylmorphine assay

March 2018

IVDs, clinical chemistry

Model: SMN 10481483 and SMN 10470440

MHRA reference: 2018/003/016/601/001


14 March 2018

Osteosynthesis, bone plates

MHRA reference: 2018/003/020/478/010

Stryker: EMS – Power-LOAD® Cot Fastener

March 2018

Moving & handling

MHRA reference: 2018/003/020/478/011

Thermofisher Scientific: Remel

23 February 2018

IVDs, bacteriology

Model: Remel R30166601

MHRA reference: 2018/003/020/601/002

Venner Medical Singapore: Venner™ Tracheal Seal Monitor

23 February 2018

Airway devices

Model: 90320

MHRA reference: 2018/003/021/291/019

William A Cook Australia (Cook Medical): Vacuum Pump

08 March 2018

Surgical equipment, miscellaneous

Model: K-MAR-5200

MHRA reference: 2018/003/016/701/039

Zimmer: Normed Charcot Osteotome Chisel

16 March 2018

Osteosynthesis, bone plates

Model: 26.08.506; 26.08.507; 26.08.508; 26.08.509; 26.08.613; 26.08.619;

MHRA reference: 2018/003/016/228/001

Published 26 March 2018