Field Safety Notices - 12 December - 16 December 2016
Summary List of field safety notices (FSNs) from medical device manufacturers from 12 - 16 December 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
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
515379
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
32051
Infant incubators
MHRA reference: 2016/012/012/291/012
Groupe Lepine: METACARPAL STEM MAIA
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
2016-074
Picture Archiving and Communication System (PACS)
MHRA reference: 2016/012/009/601/002
Merge Healthcare: Merge Eye Station
2016-073
Picture Archiving and Communication System (PACS)
MHRA reference: 2016/012/009/601/001
Merge Healthcare: Merge Eye Station
2016-078
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
Model:
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
Navilyst Medical: Navilyst
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
Cust2269
Suction equipment
Model: Instrapac
MHRA reference: 2016/011/017/601/001
Spinal Simplicity: Minuteman G3
FSN-2016-001
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
RA2016-150
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