Field safety notices - 5 to 9 October 2015

List of field safety notices (FSNs) from medical device manufacturers from 5 to 9 October 2015.

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

Ansell Healthcare Europe: Gammex PF

October 2015

Gloves, surgical and examination

MHRA reference: 2015/009/022/292/014

Armstrong Medical: AquaVent neo neonatal heated CPAP

7 October 2015

Humidifiers

Model: System REF. AMCP 1409/031

MHRA reference: 2015/009/011/291/009

Arrow International Inc: pressure injectable peripherally inserted central catheter (PICC) – 4FR

28 September 2015

Vascular cannula and catheters

Model: Arrow select kits, Arrow pressure injectable PICC kit with Blue, FlexTip, Arrow pressure injectable PICC kit with Blue FlexTip catheter, Arrow pressure injectable PICC set with Blue FlexTip catheter, EU Arrow select kits, EU special order product

MHRA reference: 2015/009/029/081/002

Bio-Rad: urinary metanephrines by HPLC (195-5411, 195-5412)

8 October 2015

IVDs, clinical chemistry

MHRA reference: 2015/010/008/292/006

Depuy Synthes: chronOS Inject bone void filler

2 October 2015

Implant materials, bone substitutes

MHRA reference: 2015/010/007/071/004

Ethicon Endo-Surgery: Harmonic ACE+7, 5 mm diameter shears, 23 cm length with advanced hemostasis

5 October 2015

Surgical power tools

Model: HARH23, HARH36, HARH45

MHRA reference: 2015/010/005/292/009

Flexicare Medical: T-piece 22mm male/ female

6 October 2015

Resuscitators

Model: 010-631

MHRA reference: 2015/009/011/292/004

GE Healthcare: Centricity PACS-IW

FMI 85410

Picture archiving and communication system (PACS)

Model: Centricity PACS-IW versions 3.5.0 through 3.7.3.9 SP2, 3.7.3 SPA10 and 4.0.1

MHRA reference: 2015/010/005/292/012

GE Healthcare: universal viewer

FMI 85413

Picture archiving and communication system (PACS

Model: Centricity PACS-IW with universal viewer versions 5.0 SP2 and higher and Centricity universal viewer versions 6.0 and higher

MHRA reference: 2015/010/006/292/012

Intelerad Medical: IntelePACS

September 2015

Picture archiving and communication system (PACS)

Model: versions 4.5.1 and up

MHRA reference: 2015/009/018/601/010

Intuitive Surgical: · da Vinci Si single-site grip release15

14 September 2015

Endoscopes, rigid

Model : 428050-12, -13, -14; · 428053-12, -15;· 428055-12, -13;· 428056-12, -13;· 428058-12, -13;· 428059-12, -13;· 428080-04, -05;· 428088-12, -13;· 428093-12, -13

MHRA reference: 2015/009/015/081/005

JenaValve Technology GmbH: The JenaValve

CC15-005

Implants, non-active, cardiovascular heart

MHRA reference : 2015/010/006/299/005

Johnson & Johnson: PowerStar bipolar cable

30 September 2015

Surgical, diathermy

MHRA reference: 2015/010/007/701/007

Mercury Medical: T-piece neonatal patient circuit kit

1 October 2015

Breathing system components

Model: M1091335VS

MHRA reference: 2015/010/002/291/030

Philips Healthcare: HeartStart defibrillator/monitor

October 2015

Defibrillators, non-implantable

Model: MRx

MHRA reference: 2015/005/022/401/019

Philips Medical: Brilliance 16-slice (Air) Brilliance 64 CT, Ingenuity Core, Ingenuity Core128, Brilliance CT Big Bore, Ingenuity Flex

FCO72800635

Computed tomography

Model: 728246 – Brilliance 16-Slice (Air), 728231 – Brilliance 64 CT, 728321 – Ingenuity Core, 728323 – Ingenuity Core128, 728243/728244 – Brilliance CT Big Bore, 728317 - Ingenuity Flex

MHRA reference: 2015/010/006/292/010

Roche Diagnostics: cobas p 612 pre-analytical system

30 September 2015

IVDs, clinical chemistry

Model: 05082579001

MHRA reference: 2015/010/002/701/010

Siemens Healthcare Diagnostics Products: Enzygnost anti-VZV / IgG

October 2015

IVDs, viral microbiology

Model: OWLT15

MHRA reference: 2015/010/005/299/003

Stryker: Exeter small and large tapered pin reamer

September 2015

Surgical instruments, implant

Model: 932-0-000 and 0932-2-000

MHRA reference: 2015/009/023/292/022

Varian Medical Systems: ARIA radiation oncology

29 September 2015

Radiotherapy planning and verification systems

MHRA reference: 2015/010/005/701/002

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