Field safety notices - 16 to 20 November 2015
List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 November 2015
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
Menarini: GlucoMen LX Sensor
November 2015
IVDs, self / home testing
MHRA reference: 2015/011/016/292/003
alamedics: ala octa
13 November 2015
Implants, non-active, intraocular
MHRA reference: 2015/011/016/291/002
bioMerieux: MYLA ® - all software versions
13 November 2015
IVDs, bacteriology
MHRA reference: 2015/011/016/292/005
Breas Medical: Home care ventilator
11 November 2015
Lung ventilators
Model: Vivo 60
MHRA reference: 2015/011/018/292/002
Christoph Miethke GmbH & Co.KG: proGAV | proGAV 2.0
18 November 2015
Implants, non-active, hydrocephalus shunts
MHRA reference: 2015/011/019/701/015
DePuy Orthopaedics Worldwide: Reach System Handle
November 2015
Surgical instruments, implant
Model: 950505154
MHRA reference: 2015/011/016/291/013
GERMITEC: ANTIGERMIX E1
12 November 2015
Sterilization methods, irradiation
MHRA reference: 2015/011/019/701/014
Infopia Co: HemoCue ® HbA1c 501
5 November 2015
IVDs, extra laboratory testing
Model: IGM-0026B
MHRA reference: 2015/011/019/181/002
Philips Healthcare Nederland B.V: Allura Xper, AlluraClarity, Allura CV, Allura Centron and UNIQ systems
26 October 2015
X-ray, fluoroscopy systems
Model: Various
MHRA reference: 2015/011/017/292/009
QIAGEN: artus C. trachomatis Plus RG & LC PCR Kits
6 November 2015
IVDs, bacteriology
Model: 4559263, 4559265, 4559063, 4559065, 4559267
MHRA reference: 2015/011/013/701/008
Siemens Healthcare : syngo X WP
19 October 2015
X-ray, general
Model: 10502522
MHRA reference: 2015/011/016/601/004
Siemens Healthcare Diagnostics: Stratus CS Acute Care diagnostics system
November 2015
IVDs, clinical chemistry
MHRA reference: 2015/011/012/601/002
Siemens Healthcare Diagnostics Inc: ADVIA Centaur; ADVIA Centaur XP
November 2015
IVDs, clinical chemistry
MHRA reference: 2015/011/018/601/002
Sorin Group Italia: Sterile Inspire custom pack
23 October 2015
Infusion & transfusion, heart lung circuits
MHRA reference: 2015/010/027/292/015
Spirit Healthcare: CareSens N glucose meters
12 November 2015
IVDs, self / home testing
MHRA reference: 2015/011/013/291/004
St. Jude Medical: Optisure dual coil defibrillation lead
4 November 2015
Implants, active, leads and electrodes
Model: LDA 220 Q52, LDA 220 Q58, LDA 220 Q65 and LDP 220 Q58
MHRA reference: 2015/011/017/299/004
Smith & Nephew: Birmingham HIP™ Modular Head 38MM~58MM Monoblock
16 November 2015
Joint Prosthesis, Hip
MHRA reference: 2015/011/018/701/012