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
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
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
Radiotherapy
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
Radiotherapy
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
FSCA-3010611950/06/09/2017/001-R
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