Field Safety Notices - 12 December - 16 December 2016

Summary List of field safety notices (FSNs) from medical device manufacturers from 12 - 16 December 2016


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

Atrium Medical: Atrium Ocean, Oasis, Express and Express Mini chest drain

30 November 2016

Chest drains and accessories

MHRA reference: 2016/012/009/291/004

Bauch& Lomb: 1.5 mmx1.7mm Trapezoid Angled 6/BOX MAXZ`160

14 September 2016

Surgical instruments, non-articulated cutting

Model: E7599

MHRA reference: 2016/009/019/701/012

CareFusion: Alaris VP Plus with Guardrails

November 2016

Infusion Systems

Model: 9003MED01-G and 9003TIG01-G

MHRA reference: 2016/012/013/701/013

Depuy Synthes: Impactor for PFNA Blade


Orthopaedic surgical instruments - impacting tools

Model: Impactor for PFNA Blade; 03.010.410

MHRA reference: 2016/012/012/291/031

Drägerwerk: Oxylog 3000 and Oxylog 3000 plus

December 2106

Lung ventilators

MHRA reference: 2016/012/012/291/014

Fresenius: sleep safe set

12 December 2016

Dialysis, peritoneal

Model: sleep•safe Set, sleep•safe Set Plus, sleep•safe Set Paed, sleep•safe Set Plus (Japanese Version), sleep•safe Set Plus AP

MHRA reference: 2016/012/008/299/005

Gambro: ArtiSet HD SN HC, Artiset HD DNL HC

December 2016

Dialysis, blood lines

Model: 1) 114533, 2) 955364

MHRA reference: 2016/012/008/291/010

GE Healthcare: Giraffe Exam Light, Giraffe Incubator, Giraffe Blue Spot PT Lite, Giraffe Omnibed, Giraffe Warmer, Panda Warmer, Panda iRes Warmer, Care Plus Incubator, Ohio Infant Warmer Systems manufactured from Mar 2003 - Apr 2010


Infant incubators

MHRA reference: 2016/012/012/291/012


28 November 2016

Joint prosthesis, finger

Model: M100 0010

MHRA reference: 2016/012/013/299/008

Maquet: Maquet Heater-Cooler Systems

05 December 2016

Blood/fluid warming systems

Model: HCU40

MHRA reference: 2016/012/013/701/012

Medtronic: Claria MRI™ CRT-D SureScan™ and Amplia MRI™ CRT-D SureScan™

12 December 2016

Implants, active, defibrillators

Model: Claria MRI™ CRT-D SureScan™ and Amplia MRI™ CRT-D SureScan™; DTMA2D1, DTMA2D4, DTMA2Q1, DTMA2QQ, DTMB1D4, DTMB1QQ, DTMB2D1, DTMB2D4, DTMB2Q1, DTMB2QQ

MHRA reference: 2016/012/012/291/017

Merge Healthcare: eFilm Workstation/eFilm Lite


Picture Archiving and Communication System (PACS)

MHRA reference: 2016/012/009/601/002

Merge Healthcare: Merge Eye Station


Picture Archiving and Communication System (PACS)

MHRA reference: 2016/012/009/601/001

Merge Healthcare: Merge Eye Station


Picture Archiving and Communication System (PACS)

MHRA reference: 2016/012/009/601/003

Nanovi Radiotherapy: BioXmark

08 December 2016

Surgical devices, non-powered

MHRA reference: 2016/012/012/291/003

Natus Medical: neoBLUE® blanket Phototherapy LED System

02 December 2016

Therapy, Infant Phototherapy


i. 007299 neoBLUE® blanket LED Phototherapy System with Large blanket/pad EUR.

ii. 006254 neoBLUE® blanket LED Light Box.

iii. 007300 neoBLUE® blanket LED Phototherapy System with Small blanket/pad EUR.

iv. 007296 neoBLUE® blanket LED Phototherapy System with Large blanket/pad UK

MHRA reference: 2016/012/007/701/010

28 November 2016

Vascular cannula and catheters

Model: Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC

MHRA reference: 2016/012/008/291/020

Oscor: Adelante Breezeway Delivery Sheath 8F & 10F

03 November 2016

Vascular cannula and catheters

Model: See Adelante Breezeway 8F and 10F Shipments for model

MHRA reference: 2016/010/006/701/018

Robinson Healthcare


Suction equipment

Model: Instrapac

MHRA reference: 2016/011/017/601/001

Spinal Simplicity: Minuteman G3


Spinal implants

MHRA reference: 2016/012/013/291/016

Synergy Health:

12 December 2016

Bandages and tapes

Model: Cotton Stretch Crepe Bandage

MHRA reference: 2016/012/012/601/001

Stryker: MIS (Minimally Invasive Surgery) Toolsteel Burs


Implants, active, defibrillators

Model: 8470-009-030, 8450-010-040, 8450-009-030, 8450-009-040, 8470-009-040, 8450-107-525, 8450-107-530

MHRA reference: 2016/012/012/701/010

Published 20 December 2016