Field Safety Notice - 5 to 9 March 2018

Summary List of field safety notices (FSNs) from medical device manufacturers from 5 to 9 March 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

Boston Scientific: Capio™ SLIM Suture Capturing Device,

Capio™ Open Access Suture Capturing Device, Capio™ Standard Suture Capturing Device, Capio™ RP Suture Capturing Device, Uphold™ LITE Vaginal Support System with Capio™ SLIM, Pinnacle™ Anterior Pelvic Floor Repair Kit, Pinnacle LITE Pelvic Floor Repair Kit, Posterior with Capio SLIM

20 February 2018

Sutures

Model: M0068312321, M0068317050, M0068318150, M0068318170, M0068318250, M0068318261, M0068321010

MHRA reference: 2018/002/014/291/009

CareFusion Switzerland 317 Sárl: Alaris™/ Asena ™ GS,GH,CC,TIVA,PK, Syringe Pumps

March 2018

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

Drager: Infinity Acute Care System (M540)

March 2018

Monitors, patient

MHRA reference: 2018/003/007/478/029

Geratherm Medical AG: Geratherm Patient Warming System UniqueTemp°

Recovery, Recovery Set 1; UniqueTemp° Pflegeset1

13 February 2018

Heating, Patient, Electrical Pads & Blankets

Model: Geratherm Patient Warming System UniqueTemp°

MHRA reference: 2018/003/008/291/006

Herco Wassertechnik: HP xxx D/x/x with Hercotherm Ring 9kW/5-4

12 February 2018

Dialysis, haemodialysis

MHRA reference: 2018/003/002/478/012

Indes B.V: Quickie Wheel Drive

27 February 2018

Wheelchairs, powered

MHRA reference: 2018/003/002/291/005

Miltenyi Biotec: Tubing Set TPE LIFE 18 - TPE Line

26 February 2018

Apheresis

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

Phadia AB: EliA anti-TSH-R well

FSN2018-01

IVDs, clinical chemistry

MHRA reference: 2018/001/031/601/004

Philips: Philips HeartStart FRx AED, Philips HS1 (Onsite) AED, Philips HS1 (Home) AED

16 February 2018

Defibrillators, non-implantable

Model: Philips HeartStart FRx AED – 861304, 861305

MHRA reference: 2018/003/005/291/002

Philips Medical Systems: Ingenuity Flex, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Brilliance iCT, Brilliance iCT SP, Brilliance Big Bore (Oncology), Brilliance Big Bore (Radiology), Brilliance 16 Slice (Air), Brilliance 16 Slice (Power), Brilliance 40, Brilliance 64, IQon Spectral CT, Brilliance 6 Slice (Air), Brilliance 10 Slice (Air), Brilliance CT Private Practice CV config

08 February 2018

Computed tomography

Model: 728317, 728326, 728325, 728321, 728323, 728324, 728306, 728311, 728243, 728244, 728246, 728240, 728235, 728231, 728332, 728256, 728251, 728241

MHRA reference: 2018/003/005/291/014

Shippert Medical Technologies: TissuTrans Filtron 100

10 January 2018

Surgical Instruments, Minimal Access

MHRA reference: 2018/003/007/478/005

Siemens Healthcare Diagnostics Inc: Atellica Solution

February 2018

IVDs, clinical chemistry

Model: Atellica Solution IM 1300 Analyzer and Atellica Solution IM 1600 IM Analyzer

MHRA reference: 2018/003/006/601/005

Sofradim (subsidiary of Covidien): Versatex™ Monofilament Mesh 50 x 50 cm

March, 2018

Implants, non-active, abdominal & hernia mesh

Model: Versatex

MHRA reference: [2018/003/006/291/002]https://mhra.filecamp.com/public/file/2rsr-66t98pq4)

Zimmer Biomet: AIM Tibial Nail

28 February 2018

Joint prosthesis, knee

MHRA reference: 2018/003/002/478/011

Zimmer Biomet: Persona Partial Knee Spacer Blocks

6 March 2018

Orthopaedic surgical instruments - insertion/extraction tools

MHRA reference: 2018/003/007/478/028

Published 12 March 2018