Weekly list of Field Safety Notices (FSNs) 11 – 15 February 2013 : MHRA

UK Health AuthorityFSNs are listed alphabetically by manufacturer name.


Andreas Hettich GmbH & Co KG 
Centrifuges.  Rotofix 32 A; 1206 / 1206.  FSN 01 December 2011PDF file (opens in new window) (242Kb).
MHRA ref: 2013/002/012/081/003

Covidien
Staples and staple guns; endoscopic linear stapler/cutter.  Endo GIA Auto Suture SULU 30mm-2.0mm.  FSN February 2013PDF file (opens in new window) (108Kb).
MHRA ref: 2013/002/011/291/011

Elekta Ltd
Radiotherapy; linac.  XVI – R3.5, R3.5.1 R4.0, R4.2, R4.2.1, R4.5, R4.5.1, R4.6.  FSN January 2013PDF file (opens in new window)(258Kb).
MHRA ref: 2013/002/005/291/011

GE Medical Systems SCS
X-ray, fluoroscopy systems fluoroscopy system.  2236709, 2353620, 2223039-2, 2270677-2 – CRT monitor suspension manufactured by GEHC.  FSN 13 February 2013PDF file (opens in new window) (114Kb).
MHRA ref: 2013/002/013/291/017

GRAFTYS
Implant materials, bone substitute. Eurospine – HRCCS4S. FSN 21 January 2013PDF file (opens in new window) (201Kb)
MHRA ref: 2013/001/031/291/022

HeartWare Inc
Implantable ventricular assist devices; ventricular – pump.  HVAD system – 1100, 1102, 1104, 1205.  FSN February 2013PDF file (opens in new window) (148Kb).
MHRA ref: 2013/002/008/291/009

Hospira Inc
Infusion systems, electrically powered infusion pump.  Plum A+.  FSN 25 January 2013PDF file (opens in new window) (991Kb).
MHRA ref: 2013/001/022/081/010

Hospira Inc
Infusion systems, electrically powered infusion pump.  Plum A+.  FSN 14 February 2013PDF file (opens in new window) (61Kb).
MHRA ref: 2013/001/024/081/012

Impac Medical Systems Inc
Radiotherapy, planning and verification systems software.  Monaco RTP System.  undated FSNPDF file (opens in new window) (110Kb).
MHRA ref: 2013/002/011/081/019

Joerns Healthcare Ltd
Hoists, moving and handling, frame.  Advance.  FSN 11 February 2013PDF file (opens in new window) (350Kb).
MHRA ref: 2012/011/007/081/020

Johnson & Johnson International / Ethicon
Suture, absorbable. Vicryl™ polyglactin 910 suture.  FSN February 2013PDF file (opens in new window) (197Kb).
MHRA ref: 2013/002/014/601/001

Limacorporate 
Joint prosthesis, hip. Spacers for Delta liners in Delta acetabular system; product codes: 5885.15.5XX, 5886.15.5XX. FSN 06 February 2013PDF file (opens in new window) (207Kb)
MHRA ref: 2013/002/011/291/001

Medtronic Inc
Implants, active, leads, neuro; neurostimulation electrodes. Deep brain stimulation (DBS) lead kits.  FSN February 2013PDF file (opens in new window) (188Kb).
MHRA ref: 2013/002/008/081/018

Newdeal / Integra
Surgical instruments. Cannulated screwdriver and screwdriver tip. FSN February 2013PDF file (opens in new window) (592Kb)
MHRA ref: 2013/002/008/081/013

Nikkiso Europe (distributor: Baxter Healthcare)
Dialysis, haemofilters; haemofiltration machine.  Aquarius.  FSN February 2013PDF file (opens in new window) (898Kb).
MHRA ref: 2008/011/024/291/007

Oraya Therapeutics Inc
Radiotherapy  treatment system. Oraya ophthalmic tray assembly.  FSN 07 February 2013PDF file (opens in new window) (1336Kb).
MHRA ref: 2013/002/008/291/001

Roche Diagnostics GmbH
IVDs, clinical chemistry instrumentation.  ALP2, CREJ2, CRPL3, UREAL, ALT, CO2-L for cobas c systems.  FSN 21 January 2013PDF file (opens in new window) (105Kb). Update to: FSN 24 October 2012PDF file (opens in new window) (240Kb).
MHRA ref: 2012/010/031/081/006

Siemens Healthcare Diagnostics Inc
IVDs, clinical chemistry reagent. Dimension® Phosphorus (PHOS) Flex® reagent cartridge.  FSN February 2013PDF file (opens in new window) (47Kb).
MHRA ref: 2013/002/012/601/013

Siemens Healthcare Diagnostics Inc
IVDs, clinical chemistry instrumentation. ADVIA LabCell and ADVIA WorkCell CDX Systems: 040-A001-XX.FSN February 2013PDF file (opens in new window) (33Kb)
MHRA ref: 2013/002/007/601/009

Siemens Medical Solutions Diagnostics
IVDs, clinical chemistry reagent.  Immulite and Immulite 1000, third generation TSH (thyroid-stimulating hormone).  FSN February 2013PDF file (opens in new window) (28Kb).
MHRA ref: 2013/002/005/601/003

SuperSonic Imagine
Ultrasound, imaging accessory.  Aixplorer.  FSN 10 January 2013PDF file (opens in new window) (558Kb).
MHRA ref: 2013/002/014/081/002

Synthes 
Spinal implants, pedicle screw. Occipital screw 4.5mm, length 8mm, titanium alloy (TAN) – 04.601.108, 04.601.108S.  FSN 11 February 2013PDF file (opens in new window) (1197Kb).
MHRA ref: 2013/002/011/291/010

Thermo Fisher Scientific
IVDs, bacteriology reagent. Oxoid antimicrobial susceptibility testing disc. FSN 07 February 2013  PDF file (opens in new window) (27Kb)
MHRA ref: 2013/002/007/601/005

Vital Images 
Standalone diagnostic workstation. Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect), Vitrea fX, and VitreaLT.  FSN 05 February 2013PDF file (opens in new window) (79Kb).
MHRA ref: 2013/002/008/081/006

Vital Signs (supplier: GE Healthcare)
Diagnostic measurement and monitoring; thermometer, electronic. Vital – Temp* general purpose probe (Vital Signs disposable general purpose 9 French temperature probes) – 1016, 1016EU, GXXXXX64.  FSN 19 December 2012PDF file (opens in new window) (174Kb). Update to: FSN October 2012PDF file (opens in new window) (162Kb).
MHRA ref: 2012/009/026/291/015

via Weekly list of Field Safety Notices 11 – 15 February 2013 : MHRA | Regulatory Doctor

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s