Field Safety Notice - 8 October to 12 October

List of field safety notices (FSNs) from medical device manufacturers from 8 October to 12 October

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

Abbott: Alinity ci-series System Control Module (SCM)

06 February 2018

IVDs, clinical chemistry

MHRA reference: 2018/010/005/228/008

Abbott: ARCHITECT HAVAb-IgG;-IgM; Alinity i HAVAB IgG

28 September 2018

IVDs, viral microbiology

MHRA reference: 2018/010/002/701/007

Aesculap ( B Braun): ENNOVATE ROD PERSUADER

31 July 2018

Orthopaedic surgical instruments

Model: SZ277R

MHRA reference: 2018/010/005/228/007

Bard: LifeStream Stent

FA2018-38

Implants, non active, peripheral vascular stents

MHRA reference: 2018/010/003/601/003

BIOMERIEUX: NUCLISENS® Lysis Buffer

10 October 2018

IVDs, viral microbiology

MHRA reference: 2018/010/011/291/005

Biomet (Zimmer Biomet): StageOne Hip Cement Spacer Mold

04 October 2018

Joint prosthesis, hip

MHRA reference: 2018/010/005/228/001

Drive Devilbiss: Konica Minolta

28 September 2018

Monitors, patient

Model: SR-5C

MHRA reference: 2018/010/004/601/003

Schaerer Medical AG: Shoulder arthroscopy plate for schaerer® axis

28 September 2018

Operating table

Model: 90568 / 90569

MHRA reference: 2018/010/010/291/001

Siemens: Artis zee ceiling

20 September 2018

X ray, fluoroscopy systems

MHRA reference: 2018/010/009/601/001

Siemens: Dimension Integrated Chemistry Systems

October 2018

IVDs, clinical chemistry

MHRA reference: 2018/010/008/601/003

Siemens: Biograph Horizon and Biograph mCT

MI517/18/S

Nuclear medicine, PET-CT

Model: 10248668, 10248669, 10248670, 10248671, 10248672,

MHRA reference: 2018/010/008/601/008

Siemens: Symbia Evo Excel

CAN 004-2018

Nuclear medicine, gamma camera systems & accessories

Model: Symbia Evo Excel 10910501

MHRA reference: 2018/010/009/601/010

Smith & Nephew: GENESIS II MIS DCF DISTAL CUTTING BLOCK

04 October 2018

Orthopaedic surgical instruments - insertion/extraction tools

MHRA reference: 2018/010/008/291/005

Stryker: ETS. Hip endoprosthesis Head

June 2018

Joint prosthesis, hip

MHRA reference: 2018/003/021/291/018

Published 15 October 2018