Field Safety Notices - 2 January - 6 January 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 2 - 6 January 2017
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
Acutronic Medical Systems
01 November 2016
Lung ventilators
Model: Fabian HFO
MHRA reference: 2016/011/015/291/011
Advanced Fiber Tools: Radial Fiber
3 January 2017
Therapy, lasers
Model: VARI-Co 360° fiber
MHRA reference: 2016/012/016/299/019
Beckman Coulter: UniCel DxH 800/600 Cellular Analysis Systems
2 December 2016
IVDs, haematology
MHRA reference: 2017/001/003/601/005
Boston Scientific: Imager™ II Angiographic Catheter
19 December 2016
Vascular cannula and catheters
Model: Recall: M001314141 Advisory: Refer to appendix A
MHRA reference: 2016/012/020/291/021
Corin: Trinity acetabular shell
18 November 2016
Joint prosthesis, hip
Model: 321.03.352
MHRA reference: 2016/011/018/601/003
Depuy Synthes: Synthes Radial Head Prosthesis
30 December 2016
Joint prosthesis, elbow
MHRA reference: 2017/001/005/299/001
Maquet: Cardiosave Hybrid/Rescue IABP Li-Ion Battery
23 December 2016
Cardiac assist pumps
Model: IABP 0998-xx-0800-xx; Battery 0146-00-0097
MHRA reference: 2016/012/029/291/010
Ortho Clinical: VITROS® Chemistry Products Na+ Slides
3 January 2016
IVDs, clinical chemistry
MHRA reference: 2017/001/002/601/001
Siemens: syngo RT Oncologist
TH006/16/S
Radiotherapy
MHRA reference: 2017/001/005/601/001
Siemens: VERSANT kPCR Molecular System Sample Preparation
4 January 2017
IVDs, viral microbiology
MHRA reference: 2017/001/004/601/009
Stryker: TLS and SPG Drain System, Medpor Facial implants
January 2017
Wound drains
Model: see attached list
MHRA reference: 2016/012/028/701/010
Zimmer Biomet: Comprehensive Reverse Shoulder Tray
20 December 2106
Joint prosthesis, shoulder
MHRA reference : 2016/012/030/701/004