Field Safety Notice: 15 to 19 July 2019

List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 July 2019

From:
Medicines and Healthcare products Regulatory Agency
Published
22 July 2019
Last updated
24 July 2019 — See all updates
Message type:
Field safety notice
Issued:
22 July 2019

Latest FSNs

View the latest FSNs

Clinical Innovations: Kiwi Complete Vacuum Delivery System

02 July 2019

Surgical equipment, miscellaneous VAC-6000MTE

MHRA reference: 2019/007/012/487/023

Dexcom: Dexcom G4 PLATINUM, Dexcom G5 Mobile

20 June 2019

Continuous glucose monitoring systems (CGMS) Model: All receivers - applies to product generatio

MHRA reference: 2019/007/001/701/021

Elekta: HexaPOD evo RT System

July 2019

Radiotherapy Model: P10603-109, P10603-110 and P10603-111

MHRA reference: 2019/007/016/701/016

Intersurgical: Swivel elbows

15 July 2019

Breathing system components

MHRA reference: 2019/007/019/291/001

Lima Corporate: DISCOVERY Elbow - Humeral condyle kit XS CoCrMo

21 June 2019

Joint prosthesis, elbow Model: 114991 and 114700

MHRA reference: 2019/007/018/487/023

Medtronic: VisualaseTM Cooled Laser Applicator System (VCLAS)

July 2019

Therapy, lasers Model: 9735559, 97355560, 9735561

MHRA reference: 2019/007/004701/024

Philips: Ingenuity CT, Ingenuity Core, Ingenuity Core 128, Brilliance 64, iCT, iCT SP, IQon, Ingenuity TF PET/CT, Vereos PET/CT

24 June 2019

Computed tomography Model: 728326 Ingenuity CT, 728321 Ingenuity Core
728323 Ingenuity Core128, 728231 Brilliance 64
728306 iCT , 728311 iCT SP, 728332 IQon Spectral CT 882456 Ingenuity TF PET/CT, 882446 Vereos PET/CT

MHRA reference: 2019/007/011/228/012

Philips: Philips Azurion system with software version 1.2

04 July 2019

X Ray, fluoroscopy systems

MHRA reference: 2019/007/018/487/015

Philips Medical: Philips Azurion system with software version 1.2

04 July 2019

X Ray, fluoroscopy systems Model: 722063, 722064, 722067, 722068, 722078, 722079

MHRA reference: 2019/007/018/487/016

Rocket Medical: Rocket Diathermy Loop Extension

CUST-OCC145 Surgical, diathermy R57818

MHRA reference: 2019/007/010/601/008

Seca: seca 402 and seca 40

17 July 2019

Trolleys and chairs Model: 402

MHRA reference: 2019/007/018/487/022

Sentinel: Lithium

28 June 2019

IVDs, clinical chemistry

MHRA reference: 2019/007/017/291/005

Thermo Fisher: Oxoid

09 July 2019

IVDs, bacteriology PO0779A

MHRA reference: 2019/007/010/601/009

Uptake Medical: InterVapor System

12 July 2019

Endoscopes, flexible Model: UM-GEN-100, UM-CTH-100, UM-IP3-100

MHRA reference: 2019/007/017/701/035

Published 22 July 2019
Last updated 24 July 2019 + show all updates

  1. We fixed some broken links to FSNs, and added a new entry for Dexcom about glucose monitoring systems.

  2. First published.