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 FSNs
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: 2019/007/029/291/003
Air Liquide: VENTILATEUR PULMONAIRE
29 July 2019
Lung ventilators Monnal T60
MHRA reference: 2019/007/029/291/008
Cell Marque Corporation: KAPPA (EP171) RABBIT MONOCLONAL PRIMARY ANTIBODY
30 July 2019
IVDs, immunology
MHRA reference: 2019/008/001/701/014
Cook Medical: Hemospray Endoscopic Hemostat
July 2019
Haemostatic agents
MHRA reference: 2019/007/022/701/036
Fritz Stephan: SOPHIE
08 July 2019
Lung ventilators
MHRA reference: 2019/007/031/701/001
GE Healthcare: OEC Fluorostar, OEC Fluorostar Compact, OEC Fluorost
15142
X Ray, fluoroscopy systems
MHRA reference: 2019/007/025/487/009
Intersurgical: One-Piece Guedel Airway, Blue, ISO 5.0, Size 00
25 July 2019
Airway devices
MHRA reference: 2019/007/025/487/011
Intuitive Surgical: da Vinci® Xi™ and da Vinci® X™ Surgical System
ISIFA2019-07-C
Endoscopes, rigid
Model: IS4000 Surgical System; IS4200 Surgical System
MHRA reference: 2019/007/025/701/015
KaVo: RONDOflex Powder 27µm 1kg
July 2019
Dental appliances / instruments
MHRA reference: 2019/007/029/291/0077
LeMaitre Vascular: LeMaitre Aortic Occlusion Catheter
26 July 2019
Vascular cannula and catheters
Model: 2107-80
MHRA reference: 2019/007/026/701/013
Medisoft Belgium: FeNO+ FE-00-01
24 June 2019
Diagnostic measurement and monitoring
MHRA reference: 2019/008/001/291/001
Occlutech: Occlutech Delivery Set
24 July 2019
Implants, non-active, cardiac appendage and septal defect occluders / Plugs
MHRA reference: 2019/007/026/487/006
Siemens: IMMULITE/IMMULITE 1000/2000
July 2019
IVDs, clinical chemistry
MHRA reference: 2019/007/015/601/007
Siemens: ADVIA Centaur Folate
July 2019
IVDs, clinical chemistry
MHRA reference: 2019/007/026/601/008
Spectrum: Quantum Pump Console
29 May 2019
Heart lung machines
QPC
MHRA reference: 2019/007/012/601/006
The Binding Site: Optilite IgM kit
29 July 2019
IVDs, immunology
Model: NK012.OPT
MHRA reference: 2019/007/029/601/024