Field Safety Notices - 6 - 10 June 2016

Summary List of field safety notices (FSNs) from medical device manufacturers from 6 - 10 June 2016

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

Baxter: Vivia System

26 May 2016

Dialysis, haemodialysis

Model: 5H51101

MHRA reference: 2016/005/027/299/005

Corin: TaperFit

6 June 2016

Joint prosthesis, hip

Model: 588.3801

MHRA reference: 2016/006/006/601/007

Dentsply: Implant Pick-Up EV 5.4 Short

3 June 2016

Implants, dental

MHRA reference: 2016/006/009/701/004

Gas Control Equipment: MARS II

1 June 2016

Resuscitators

Model: MARS II 0715212, 0715216, 0715217, 0715226

MHRA reference: 2016/006/003/601/005

GE Medical: Revolution CT

FMI 25469

Computed tomography

MHRA reference: 2016/005/009/291/006

GE Medical:Revolution CT

FMI25468

Computed tomography

MHRA reference: 2016/006/003/299/003

Impac Medical Systems: MOSAIQ

FCA-IMS-0014

Radiotherapy

Model: Versions 2.62 and higher with the IQ Scripts license enabled

MHRA reference: 2016/006/010/299/001

Milestone: VACUUM BAG DU LARGE and VACUUM BAG 5U SMALL

26 May 2016

IVDs, specimen receptacles

MHRA reference: 2016/006/007/299/019

Maquet Critical Care: FLOW-i

1 June 2016

Anaesthetic machines & monitors Model: 6677200 FLOW-i C20, 6677300 FLOW-i C30, 6677400 FLOW-i C40

MHRA reference: 2016/006/001/299/021

Philips: Brilliance 64, Ingenuity Core, Ingenuity Core128

8 April 2016

Computed tomography

Model: 728231, 728321, 728323

MHRA reference: 2016/004/026/291/008

Smith & Nephew: various

6 June 2016

Joint prosthesis, hip

MHRA reference: 2016/006/006/299/026

Stryker:Target Detachable Coils

3 June 2016

Implants, non-active, embolisation products

MHRA reference: 2016/006/008/701/017

STERIS: V-PRO® 1, V-PRO® 1 Plus, and V-PRO maX® Sterilizer

30 May 2016

Cssd wash/clean/drying equipment

MHRA reference: 2016/006/003/291/004

Tosoh: ST AIA-PACK iE2 and ST AIA-PACK hsE2

8 June 2016

IVDs, clinical chemistry

MHRA reference: 2016/006/006/299/011

Ultradent products: InterGuard

29 December 2015

Dental appliances / instruments

MHRA reference: 2015/012/029/701/001

Wieland Dental + Technik: Zenostar MT Color Liquids

May 2016

Dental materials

MHRA reference: 2016/005/024/291/001

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