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 FSNs
Boston Scientific: Xenform - Uphold - Polyform - Pinnacle
29 April 2019
Implants, non active, implantable incontinence and prolapse devices
Model: Xenform™ Tissue Repair
MHRA reference: 2019/004/029/291/001
Cook Medical: Zenith Alpha Abdominal Endovascular Graft
25 April 2019
Implants, non-active, endoprostheses for aortic aneurysms
MHRA reference: 2019/004/026/487/001
Cook Medical
17 April 2019
Implants, non-active, non-vascular stents
MHRA reference: 2019/005/001/701/036
DiaMed (Bio Rad): IH-QC1
29 April 2019
IVDs, clinical chemistry
MHRA reference: 2019/006/001/487/010
EBR System: WiSE CRT Electrode and Delivery Catheter
26 April 2019
Implants, active, intracardiac (leadless)
MHRA reference: 2019/005/001/701/011
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® Dilation Atrioseptostomy Catheter 5FR 50 cm ster. F/nat. rub. Latex. - 830515F - Catheter, Miller Balloon 5FR 50 cm Atrioseptostomy W/nat. rub. LatexFogarty® Dilation Atrioseptostomy Catheter.
FCA 131
Vascular cannula and catheters
Model: 830705F / 830515F
MHRA reference: 2019/004/024/701/023
GE Healthcare: Achilles EXP II
FMI 14018
Ultrasound, imaging
MHRA reference: 2019/004/030/487/015
Gambro (Baxter): FA-2019-019
01 May 2019
Dialysis, haemofilters
Model: Prismaflex
MHRA reference: 2019/004/030/487/013
Millipore: Bioscot Anti-C Blood Grouping Reagent (MS-273)
April 2019
IVDs, blood transfusion
Model: TW-5ML-B
MHRA reference: 2019/004/011/601/004
ORGENTEC Diagnostika: ENAcombi (aRG 514)
18 March 2019
IVDs, immunology
MHRA reference: 2019/005/001/291/005
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: 2019/005/001/291/008
Philips: Efficia 3/5 ECG Trunk Cable, AAMI/IEC
March 2019
ECG
MHRA reference: 2019/005/002/487/013
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: 2019/004/030/601/004
Surgimax: AEROtube®
28 March 2019
Airway devices
Model: AEROtube® - LK02-GB-M, Fiber Optics Laryngoscope Handles ECO (LED)
MHRA reference: 2019/003/029/601/002
Zimmer: Alvarado™ Knee Holder
30 April 2019
Orthopaedic surgical instruments - holding tools
MHRA reference: 2019/004/030/487/018