Field Safety Notice: 4 to 8 February 2019
List of field safety notices (FSNs) from medical device manufacturers from 4 to 8 February 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
Abbott: ARCHITECT Estradiol Reagent Kit Alinity i Estradiol Reagent Kit
05 February 2019
IVDs, clinical chemistry
MHRA reference: 2019/002/006/701/011
Applied Medical: CFF05 5x75mm Kii Fios Advanced Fixation Access Sys
January 2019
Surgical instruments, minimal access CFF05
MHRA reference: 2019/002/006/291/007
Arthrex: Burr, Oval, 12 Flute, 5.5 mm x 13 cm
R519_UK
Surgical power tools
AR-8550OBT
MHRA reference: 2019/001/024/487/006
Boston Scientific: ACCOLADE, ALTRUA 2, ESSENTIO, PROPONENT, VALITUDE, VISIONIST
January 2019
Implants, active, pacemakers
MHRA reference: 2017/012/019/291/016
Boston Scientific: VALITUDE™, VISIONIST™ CRT-P and CHARISMA™ , MOMENTUM™, RESONATE™, VIGILANT™, AUTOGEN™, DYNAGEN™, INOGEN™, ORIGEN™ CRT-D
January 2019
Implants, active, cardiac
MHRA reference: 2017/012/019/291/018
Drive DeVilbiss: Forearm Crutches
07 January 2019
Walking aids, crutches
MHRA reference: 2018/011/021/401/001
Edwards Life Sciences: Edwards Commander Delivery System
FCA 123
Implants, non-active, cardiovascular heart valves
9600LDS20A, 9600LDS20J, 9600LDS23A, 9600LDS23J, 9600LDS26A, 9600LDS26J, 9600LDS29A, 9600LDS29J, 9610TF20, 9610TF23, 9610TF26, 9610TF29
MHRA reference: 2019/002/006/291/009
Elekta: Monaco RTP System
February 2018
Radiotherapy planning and verification systems
MHRA reference: 2019/002/006/701/020
JRI Orthopaedics: Cemented Acetabular Cups
25 January 2019
Joint prosthesis, hip
Model: 02-28-XX
MHRA reference: 2019/001/021/601/001
Johnson & Johnson: Ethicon Ethibond Excel Suture, Size 2-0
01 February 2019
Sutures
MHRA reference: 2019/002/004/291/008
Pall Life Sciences: Ultipor 25 / Breathing System Filter
04 February 2019
Breathing system components
MHRA reference: 2019/002/004/701/009
Penlon: MAC 3 Penlon
04 February 2019
Airway devices
MHRA reference: 2018/009/004/401/012
Randox Laboratories: Immunoassay Premium Plus Controls
REC369
IVDs, clinical chemistry
Model: Immunoassay Premium Plus Controls IA3109 & IA3112
MHRA reference: 2019/002/001/601/004
Rhondium: OVC3
01 February 2019
Implants, dental
Model: 1. OVC3 24/25 L A2
MHRA reference: 2019/001/030/487/009
Siemens: Acuson NX2, NX2 Elite, NX3, NX3 Elite
US038/18/S
Ultrasound, imaging
Model: 11284381,11362069,11235612,11235411
MHRA reference: 2019/002/005/601/006
Spacelabs: Smart Disclosure
28 January 2019
Monitors, patient
Model: 92810
MHRA reference: 2019/002/004/291/011
US Endoscopy Group: Padlock Clip defect closure system
01 February 2019
Clip appliers
Model: C910001
MHRA reference: 2019/002/004/701/001
WallacOy: DELFIA / AutoDELFIA hCG Kit
08 January 2019
IVDs, clinical chemistry
Model: A082-101/ B082-101, A007-101 / B007-101 and B007-112
MHRA reference: 2019/001/007/291/007