Field Safety Notices - 30 May - 3 June 2016
Summary List of field safety notices (FSNs) from medical device manufacturers from 30 May - 3 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
Beckman Coulter: ALT (OSR6x07) and Glucose STAT (OSR6x40)
31 May 2016
IVDs, clinical chemistry MHRA reference: 2016/005/031/601/005
Drägerwerk: VentStar Oxylog3000F (P) 190
May 2016
Breathing system components
MHRA reference: 2016/005/026/291/008
FUJIFILM: Fujifilm Synapse PACS
19 May 2016
Picture Archiving and Communication System (PACS)
MHRA reference: 2016/005/018/291/015
Immucor: LIFECODES HLA-C eRES SSO Typing Kit
29 April 2016
IVDs, immunology MHRA reference: 2016/005/027/701/010
Kimal: Introducer needle 18G
27 May 2016
Injection devices
Model: K6/1
MHRA reference: 2016/005/027/601/007
Mathys: Affinis implants with Ti/CaP coating
May 2016
Joint prosthesis, shoulder Model: 60.21.0000; 60.21.0001; 60.30.3150; 60.30.3151; 60.30.6390; 60.30.6393; 60.30.6420; 60.30.6423; 62.34.0010; 62.34.0011; 62.34.0012; 62.34.0013; 62.34.0014; 62.34.0015
MHRA reference: 2016/006/001/701/002
Medtronic: MyCareLink Patient Monitor
31 May 2016
Implants, active, monitors and recorders Model: 24950
MHRA reference: 2016/005/027/299/003
RaySearch Laboratories: RayStation
24 May 2016
Radiotherapy planning and verification Model: RayStation 5
MHRA reference: 2016/006/001/291/009
Roche: Accu-Chek Insight System
SB_RDC_2016_07
Infusion systems
MHRA reference: 2016/006/001/701/009
Siemens: ADVIA Centaur XPT System
31 May 2016
IVDs, clinical chemistry MHRA reference: 2016/006/001/601/008
Smith & Nephew: Legion Hinge Knee Femoral Assembly
26 May 2016
Joint prosthesis, knee MHRA reference: 2016/005/027/291/008
Smith & Nephew: Allevyn Cavity 9cm X 2.5cm Tubular Wound Dressings
20 May 2016
Basic dressings, absorbents, swabs, procedure packs
Model: Small tubular
MHRA reference: 2016/006/002/291/001
Stanmore: METS Femoral Plateau Plate
31 May 2016
Joint prosthesis, knee MHRA reference: 2016/006/001/291/015
Sysmex Corporation Sysmex Corporation: FLUOROCELL PLT
27 May 2016
IVDs, haematology
MHRA reference: 2016/006/001/299/005
iMDsoft: MetaVision Suite, Clinical Information System&EHR
May 2016
Monitors, patient
MHRA reference: 2016/006/001/291/011