Field Safety Notice: 13 to 17 May 2019
List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 May 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
Becton Dickinson: Alaris™ Pump Module 8100 and assemblies
17 May 2019
Infusion systems
Alaris™ Pump Module 8100 and assemblies
MHRA reference: 2019/005/015/291/008
BEAVER-VISITEC INTERNATIONAL: BVI OPHTHALMIC FLUID CONTROL SPONGES
24 April 2019
Optical, ophthalmic instruments and equipment
MHRA reference: 2019/004/029/487/017
Change Healthcare: Horizon/McKesson Cardiology Hemo
22 March 2019
Monitors, patient
Horizon Cardiology Hemo 12.2,
MHRA reference: 2019/005/014/291/005
Ethicon Endo-Surgery LLC
ENSEAL X1 tissue sealer curved jaw
Surgical, diathermy
MHRA reference: 2019/005/013/701/010
Fresenius: Orchestra Base Intensive and Orchestra Base Primea
13 May 2019
Infusion systems
Z081230 and Z081330
MHRA reference: 2019/005/001/291/002
Heinrich Medical
16 May 2019
Surgical, diathermy
MHRA reference: 2019/005/013/206/001
Maquet - Getinge QUADROX-i Neonatal Microporous Membrane Oxygenator
10 May 2019
Infusion and transfusion, heart lung circuits
MHRA reference: 2019/005/013/487/004
Medline Industries: Canister for large fluid volume collection
15 May 2019
Surgical equipment, miscellaneous
MHRA reference: 2019/005/015/487/007
Medtronic: Astra™, Azure™, Percepta™, Serena™, Solara™
May 2019
Implants, active, pacemakers
Model: W1DR01, W2DR01, W3DR01, W1SR01, W2SR01 W3SR01, X2DR01, X3DR01, X2SR01, X3SR01, W1TR01, W1TR04, W4TR01, W4TR04, W1TR02, W1TR05, W4TR02, W4TR05, W1TR03, W1TR06, W4TR03, W4TR06
MHRA reference: 2019/005/013/487/005
Olympus: EVIS EXERA(Q190V)-/LUCERA(Q290V) DUODENOVIDEOSCOPE
May 2019
Endoscopes, flexible
TJF-Q190V and TJF-Q290V
MHRA reference: 2019/005/013/487/001
Pennine Healthcare: Brand
8 May 2019
Naso gastric feeding tube
Feeding Tubes, Levins Tubes, Neleton Catheters, Rectal Catheter, Ryles Tubes, Stomach Tubes, Suction Catheters, Medical Packs - Multiple,
MHRA reference: 2019/005/008/601/004
Pfizer: ThermaCare Lower Back and Hip Heatwraps
13 May 2019
Heating, patient, electrical pads and blankets
MHRA reference: 2019/005/010/291/006
Randox Laboratories: Pancreatic Amylase
1 May 2019
IVDs, clinical chemistry
Model: AY3855
MHRA reference: 2019/005/009/601/009
Siemens: IVDs, Clinical Chemistry
May 2019
Atellica CH analyzer creatine kinase
MHRA reference: 2019/005/015/291/006
Siemens: ADVIA
May 2019
IVDs, clinical chemistry
MHRA reference: 2019/005/013/601/004