Field Safety Notice - 27 to 29 December 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 27 to 29 December 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
View the latest FSNs
Aesculap: DS-SINGLE FIRE LIG. CLIPS
13 December 2017
Clip appliers
Model: DS Titanium Ligation-Clips
MHRA reference: 2017/012/022/291/001
Boston Scientific: SpyScope™ DS Access and Delivery Catheter
December 2017
Endoscopes, flexible
MHRA reference: 2017/012/022/291/003
Depuy Synthes: SIGMA® HP PFJ Cemented Trochlear Implants.
December 2017
Joint prosthesis, knee
Model: 102403100,102403200,102403300,102403400, 102403500
MHRA reference: 2017/012/028/291/003
Establishment Labs: Motiva Implants
21 December 2017
Implants, breast
MHRA reference: 2017/012/022/291/006
GE: Carescape R860
December 2017
Lung ventilators
Model: Carescape R860; GTIN # 00840682102346
MHRA reference: 2017/012/0 22/291/015
Medtronic: Medtronic Clip Gun™ Scalp Clip System
December 2017
Clip appliers
Model: CG8900, CG8901 and CG8901A
MHRA reference: 2017/012/022/291/002
Merit Medical: Prelude SNAP™ Splittable Sheath Introducer
Prelude SNAP recall
Vascular cannula and catheters
MHRA reference: 2017/012/022/291/005
Roche: Cobas u 601 urine analyzer, Model No. 06390498001
cobas u 701 microscopy analyzer, Model No. 06390501001
21 December 2017
IVDs, clinical chemistry
Model: Cobas u 601 urine analyser
MHRA reference: 2017/012/022/291/007
Siemens: All artis systems with Wireless foot switch
18 September 2017
X ray, fluoroscopy systems
MHRA reference: 2017/012/022/601/007
Siemens: Artis systems
5 December 2017
X ray, fluoroscopy systems
Model: ARTIS Systems operated with ARTIS tables
MHRA reference: 2017/012/022/601/005
Stanmore: Custom Implants with MIG component
21 December 2017
Joint prosthesis, knee
MHRA reference: 2017/012/022/291/020
Roche (Ventana): OptiView DAB IHC Detection Kit, ultraView Universal DAB Detection Kit, iView DAB Detection Kit, ultraView SISH Detection Kit, CINtec PLUS Cytology Kit (CE-IVD), OptiView Amplification Kit, Hematoxylin II
25 January 2018
Instrumentation/platform
Model: OptiView DAB IHC Detection Kit,
MHRA reference: 2017/012/022/291/012