Field safety notices - 25 to 29 January 2016
List of field safety notices (FSNs) from medical device manufacturers from 25 January to 29 January 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
Abbott Ireland Diagnostics Division: ARCHITECT STAT High Sensitive Troponin-I
21 January 2016
IVDs, clinical chemistry
MHRA reference: 2016/001/022/701/003
Accuray Incorporated: CyberKnife robotic radiosurgery system
22 January 2016
Radiotherapy
Model: CyberKnife G4, G3, VSI
MHRA reference: 2016/001/022/701/006
Agfa HealthCare: Digital radiography X-ray system
VR0000288
X-ray, digital acquisition systems
Model: DX-D 100
MHRA reference: 2016/001/022/299/006
Arrow International: Super Arrow-Flex percutaneous sheath introducer set
21 January 2016
Vascular cannula and catheters
MHRA reference: 2016/001/022/291/009
Baxter: Sterile water for irrigation, 1000 ml
January 2016
Surgical equipment, miscellaneous
MHRA reference: 2016/001/025/299/018
Bio-Rad Medical Diagnostics: Anti-Jka (JK1)
25 January 2016
IVDs, blood transfusion
Model: 808176
MHRA reference: 2016/001/025/701/005
Mast Group Ltd: Mast Cephalexin 16ug 96 well pre-poured susceptibility test plate
C5720
IVDs, Bacteriology
Model: MPM-CFX16
MHRA reference: 2016/001/028/601/004
Phadia: EliaA SmD well
28 December 2015
IVDs, Immunology
Model: Smith antibody (anti-Sm) IVD, kit fluorescent immunoassa
MHRA reference: 2015/012/030/601/001
Philips Respironics: Trilogy 100, Trilogy 200, Garbin, Garbin Plus, Trilogy O2, Trilogy 202, Trilogy EC
R-01-2016-A
Lung ventilators
MHRA reference: 2016/001/022/299/005
Physio-Control Operations: Lifepak 15 monitor/defibrillator
January 2016
Defibrillators, non-implantable
MHRA reference: 2015/003/016/401/015
Sekisui Diagnostics: Sekure acetaminophen L3K assay
22 January 2016.
IVDs, clinical chemistry
MHRA reference: 2016/001/025/299/011
Zimmer: LPS-Flex precoat femoral A-L
January 2016
Joint prosthesis, knee MHRA reference: 2016/001/022/291/002