Field safety notices - 24 to 28 August 2015
List of field safety notices (FSNs) from medical device manufacturers from 24 to 28 August 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
Amanta Healthcare: Emergency Sterile Eye Wash (Sodium chloride 0.9% w/v Ph.Eur
20 August 2015
Contact Lenses, Care Products
MHRA reference: 2015/008/024/291/001
Apatech: Actifuse ABX, Actifuse MIS System, Inductigraft
August 2015
Implant Materials, Bone Substitutes
MHRA reference: 2015/008/024/291/039
bioMerieux: chromID™ S.aureus agar Ref.43371chromID™ MRSA agar / chromID™ S. aureus agar (MRSA/SAID) – Ref. 43466chromID™ MRSA agar / chromID™ S. aureus agar (MRSAV1/SAID) (for US only) – Ref. 414524
19 August 2015
IVDs, Bacteriology
MHRA reference: 2015/008/021/291/001
Charder electronic: Charder Weigh Scale
18 August 2015
Therapy, Scales
Model: MHS 2500
MHRA reference: 2015/005/008/292/008
Edwards Life Sciences: Edwards Commander Delivery System
20 August 2015
Implants, Non Active, Cardiovascular Heart Valves
Model: 9610TF23, 9610TF26, 9610TF29
MHRA reference: 2015/002/010/081/024
GE Medical Systems: Lightspeed 16 CT, PET Discovery ST 16, LightSpeed Ultra 16, PET Discovery LS, and LightSpeed Pro 16
FMI25463
Computed tomography
MHRA reference: 2015/008/021/291/012
One Lambda: LABType HD DRB1 typing test
26 August 2015
IVDs, immunology
Model: RSSOH2B1
MHRA reference: 2015/008/028/291/012
Philips Medical Systems: Brilliance 64, Ingenuity CT, Ingenuity Core, Ingenuity Core128
18 July 2014
Computed tomography
Model: 728231: Brilliance 64, 728326: Ingenuity CT, 728321: Ingenuity Core 728323: Ingenuity Core128
MHRA reference: 2015/008/027/081/008
Physio-Control: LIFEPAK 1000 defibrillator
May 2015
Defibrillators, non implantable
Model: 320371500xxx
MHRA reference: 2015/008/026/291/002
Siemens AG Healthcare: syngo RT Therapist / PRIMUS, ONCOR, ARTISTE
TH001/15/S und TH002/15/S
Radiotherapy
Model: 008162815 // 04504200, 05857912, 07360717, 09139789
MHRA reference: 2015/008/024/601/001
Siemens AG Healthcare: syngo RT oncologist
TH003/15/S
Radiotherapy
Model: 010568604
MHRA reference: 2015/008/024/601/003
Siemens Healthcare Diagnostics: ADVIA Centaur Systems HBsAg II
August 2015
IVDs, clinical chemistry
Model: 10492138
MHRA reference: 2015/008/027/601/008
Siemens Medical Solutions: ACUSON SC2000
UI US024/15/S
Ultrasound, imaging
Model: 10433816
MHRA reference: 2015/008/025/601/001
Siemens Healthcare Diagnostics: syngo lab data manager
ISW-15-05.A.OUS - August 2015
IVDs, Clinical Chemistry
Model: 10638933, 10624077, 10804573
MHRA reference: 2015/008/027/601/001
Siemens Healthcare Diagnostics: measurement cartridge, Rapidpoint 500 (Mcart LAC)
CC 15-23.A.OUS - August 2015
IVDs, extra laboratory testing
MHRA reference: 2015/008/027/601/010
Smiths Medical: Medfusion™ Stopcocks, 4-way, Medfusion™ Stopcocks, 3-way, Medfusion™ Stopcocks, 1-way
03 August 2015
Infusion & transfusion, connectors
MHRA reference: 2015/008/006/291/002
Stryker Instruments-Kalamazoo: Neptune 2 Docking Station – Actuator Assembly
25 August 2015
Surgical devices, non-powered
MHRA reference: 2015/008/019/291/002
Synergy Health: Zethon
29 July 2015
Surgical, diathermy
Model: VC-094-D, VC-096-D, VC-099-D
MHRA reference: 2015/007/030/601/004
Teleflex: Flexi‐Slip Endotracheal Tube Stylet with soft distal tip Flexislip Stylet, sterile pack
24 August 2015
Airway Devices
MHRA reference: 2015/008/024/291/042