Field Safety Notice - 19 to 23 June 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 June 2017


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.

Biomet UK: Delta Ceramic Femoral Head 32/0mm

20 June 2017

Joint prosthesis, hip

MHRA reference: 2017/006/021/291/019

bioMérieux SA: BK Virus R-gene® Real-time Detection and Quantification Kit

19 June 2017

IVDs, viral microbiology

MHRA reference: 2017/006/020/291/010

Datascope Corp: Datascope Intra-Aortic Balloon Pump

19 June 2017

Cardiac assist pumps

Model: CS100, CS100i and CS300 IABP

MHRA reference: 2017/006/021/291/013

DYSIS Medical Ltd: DYSIS Digital Colposcope

26 June 2017

Endoscopes, flexible

Model: DYS302

MHRA reference: 2017/006/021/291/001

Elekta: MOSAIQ

June 2017


MHRA reference: 2017/006/016/701/002

Endologix: AFX EndoVascular AAA System

June 2017

Implants, non active, endoprostheses for aortic aneurysms

Model: All models containing Strata graft material - see list in FSN attached

MHRA reference: 2017/006/019/601/001

Gambro: AK 98, 230V, Efficient; AK 98,230V, Bio Version; AK 98,115V, Bio Version; AK 98,230V, Self-Care; AK 98,115V, Self-Care

June 2017

Dialysis, haemodialysis

Model: 115244, 115248, 115249, 115250, 115251, 955106

MHRA reference: 2017/006/019/291/032

Hamilton Medical: IntelliCuff Standalone

24 May 2017

Airway devices

Model: 951001

MHRA reference: 2017/006/020/291/017

Illumina: MiSeqDx Cystic Fibrosis 139-Variant Assay (2 Runs)

14 June 2017

IVD, genetic testing

Model: PN 15036580

MHRA reference: 2017/006/019/601/007

Medical Intelligence Medizintechnik: HexaPOD evo RT System / Medical Intelligence Mediz P10603-109 and P10603-110

June 2017


MHRA reference: 2017/006/019/701/015

Medline International France: Surgical procedure kit - Several

08 June 2017

Surgical devices, non-powered

Model: Surgical procedure kit

MHRA reference: 2017/006/012/291/018

Natus: Nicolet® Elite® Probes


Ultrasound, imaging

Model: X1L001, X1L004, X1L007, X1L008

MHRA reference: 2017/006/015/701/007

Ortho-Clinical: VITROS Chemistry Products PHYT Slides

June 2017

IVDs, clinical chemistry

MHRA reference: 2017/006/015/601/001

Spiegelberg: External Lumbar Drainage Catheter

15 February 2017

Cerebrospinal fluid drainage, external

Model: External Lumbar Drainage Catheter ELD33.010.02

MHRA reference: 2016/009/008/299/004

Published 26 June 2017