Field Safety Notice: 29 July to 2 August 2019
List of field safety notices (FSNs) from medical device manufacturers from 29 July to 2 August 2019
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
View the latest
Air Liquide: For GMDN code 36289 => MONNNAL T60 and MONNAL T60 JP, For GMDN code 47244 => MONNAL T75 MONNAL T75 JP and MONNAL T75 CO2, For GMDN code 42411 => MONNAL T50, MONNAL T50 DE and MONNAL T50 JP, For GMDN code 36943 => MONNAL T40, MONNAL T40 DE
29 July 2019
Lung ventilators
MHRA reference:
Air Liquide: VENTILATEUR PULMONAIRE
29 July 2019
Lung ventilators Monnal T60
MHRA reference:
Cell Marque Corporation: KAPPA (EP171) RABBIT MONOCLONAL PRIMARY ANTIBODY
30 July 2019
IVDs, immunology
MHRA reference:
Cook Medical: Hemospray Endoscopic Hemostat
July 2019
Haemostatic agents
MHRA reference:
Fritz Stephan: SOPHIE
08 July 2019
Lung ventilators
MHRA reference:
GE Healthcare: OEC Fluorostar, OEC Fluorostar Compact, OEC Fluorost
15142
X Ray, fluoroscopy systems
MHRA reference:
Intersurgical: One-Piece Guedel Airway, Blue, ISO 5.0, Size 00
25 July 2019
Airway devices
MHRA reference:
Intuitive Surgical: da Vinci庐 Xi鈩� and da Vinci庐 X鈩� Surgical System
ISIFA2019-07-C
Endoscopes, rigid
Model: IS4000 Surgical System; IS4200 Surgical System
MHRA reference:
KaVo: RONDOflex Powder 27碌m 1kg
July 2019
Dental appliances / instruments
MHRA reference:
LeMaitre Vascular: LeMaitre Aortic Occlusion Catheter
26 July 2019
Vascular cannula and catheters
Model: 2107-80
MHRA reference:
Medisoft Belgium: FeNO+ FE-00-01
24 June 2019
Diagnostic measurement and monitoring
MHRA reference:
Occlutech: Occlutech Delivery Set
24 July 2019
Implants, non-active, cardiac appendage and septal defect occluders / Plugs
MHRA reference:
Siemens: IMMULITE/IMMULITE 1000/2000
July 2019
IVDs, clinical chemistry
MHRA reference:
Siemens: ADVIA Centaur Folate
July 2019
IVDs, clinical chemistry
MHRA reference:
Spectrum: Quantum Pump Console
29 May 2019
Heart lung machines
QPC
MHRA reference:
The Binding Site: Optilite IgM kit
29 July 2019
IVDs, immunology
Model: NK012.OPT
MHRA reference: