Field Safety Notice: 29 April to 3 May 2019
List of field safety notices (FSNs) from medical device manufacturers from 29 April to 3 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
Boston Scientific: Xenform - Uphold - Polyform - Pinnacle
29 April 2019
Implants, non active, implantable incontinence and prolapse devices
Model: Xenform鈩� Tissue Repair
MHRA reference:
Cook Medical: Zenith Alpha Abdominal Endovascular Graft
25 April 2019
Implants, non-active, endoprostheses for aortic aneurysms
MHRA reference:
Cook Medical
17 April 2019
Implants, non-active, non-vascular stents
MHRA reference:
DiaMed (Bio Rad): IH-QC1
29 April 2019
IVDs, clinical chemistry
MHRA reference:
EBR System: WiSE CRT Electrode and Delivery Catheter
26 April 2019
Implants, active, intracardiac (leadless)
MHRA reference:
Edwards Lifesciences: All lots manufactured between December 13, 2017 and January 18, 2019 and shipped between the dates of December 2017 and February 2019. Commercial name/brand name/make: - 830705F - Catheter, Fogarty庐 Dilation Atrioseptostomy Catheter 5FR 50 cm ster. F/nat. rub. Latex. - 830515F - Catheter, Miller Balloon 5FR 50 cm Atrioseptostomy W/nat. rub. LatexFogarty庐 Dilation Atrioseptostomy Catheter.
FCA 131
Vascular cannula and catheters
Model: 830705F / 830515F
MHRA reference:
GE Healthcare: Achilles EXP II
FMI 14018
Ultrasound, imaging
MHRA reference:
Gambro (Baxter): FA-2019-019
01 May 2019
Dialysis, haemofilters
Model: Prismaflex
MHRA reference:
Millipore: Bioscot Anti-C Blood Grouping Reagent (MS-273)
April 2019
IVDs, blood transfusion
Model: TW-5ML-B
MHRA reference:
ORGENTEC Diagnostika: ENAcombi (aRG 514)
18 March 2019
IVDs, immunology
MHRA reference:
Philips: EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50 and Affiniti 70
26 April 2019
Ultrasound, imaging
MHRA reference:
Philips: Efficia 3/5 ECG Trunk Cable, AAMI/IEC
March 2019
ECG
MHRA reference:
Siemens: Artis zee and Artis Q/Q.zen
5 April 2019
X ray, fluoroscopy systems
Model: Artis zee and Artis Q/Q.zen systems delivered since May 2018
MHRA reference:
Surgimax: AEROtube庐
28 March 2019
Airway devices
Model: AEROtube庐 - LK02-GB-M, Fiber Optics Laryngoscope Handles ECO (LED)
MHRA reference:
Zimmer: Alvarado鈩� Knee Holder
30 April 2019
Orthopaedic surgical instruments - holding tools
MHRA reference: