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