Field Safety Notice - 15 October to 19 October
List of field safety notices (FSNs) from medical device manufacturers from 15 October to 19 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 hq Analyzer Alinity hs Slide Maker Stainer Module
11 October 2018
IVDs, haematology MHRA reference: 2018/010/016/487/012
Abbott: Alinity Free T3 Reagent Kit and Alinity Total T3 Reagent Kit
12 October 2018
IVDs, clinical chemistry
MHRA reference: 2018/010/016/487/009
Abbott (Architect): ARCHITECT Free T3 Reagent Kit and ARCHITECT Total T3 Reagent Kit
12 October 2018
IVDs, clinical chemistry
MHRA reference: 2018/010/016/487/010
Abbott (Architect): ARCHITECT HAVAb-IgG;-IgM; Alinity i HAVAB IgG
17 October 2018
VDs, Viral Microbiology
MHRA reference: 2018/010/018/291/010
Alba Bioscience (Quotient): ALBAcyte® RhD Negative CAT Reagent Red Cells for Antibody Screening
15 October 2018
IVDs, blood transfusion
Model: Z466
MHRA reference: 2018/010/016/601/003
Biomet (Zimmer Biomet): Mallory-Head Acetabular Shell
18 October 2018
Joint Prosthesis, Hip
MHRA reference: 2018/010/018/291/007
Biomet (Zimmer Biomet): Rapid Flap SpinDown Clamp
16 October 2018
Osteosynthesis, Bone Plates
MHRA reference: 2018/010/016/487/014
Covidien (Medtronic): Parietex™ Composite Parastomal Mesh
October 2018
Surgical mesh for hernia repair.
MHRA reference: 2018/010/015/291/018
Depuy Synthes: CORAIL® Female Broaches
15 October 2018
Surgical instruments, non articulated cutting
MHRA reference: 2018/010/015/291/026
Endologix: Nellix, Endovascular Aneurysm Sealing System
15 October 2018
Implants, non active, endoprostheses for aortic aneurysms
Model: N10-100, N10-110, N10-120, N10-130, N10-140, N10-150,N10-160, N10-170, N10-180, N10-190, N10-200, NP-002; NP-004; NP-001; NP-003; NP-005; NX-001, NX-002a
MHRA reference: 2018/010/015/601/003
GE Healthcare: CARESCAPE Monitor B450, B650, B850
FMI 36127A
Monitors, patient
MHRA reference: 2018/010/017/291/003
Illumina: VeriSeq NIPT Solution
16 October 2018
IVD, genetic testing
Model: 15076164
MHRA reference: 2018/010/015/601/002
Immucor: Pak LxTM Assay
06 January 2017
IVDs, clinical chemistry
MHRA reference: 2018/010/017/291/011
Maquet (Getinge): QUDROX-i Neonatal Microporous Membrane Oxygenator
12 November 2018
Infusion & transfusion, heart lung circuits
Model: 70104.8599; 70104.8600; 70104.6979; 70104.7003
MHRA reference: 2018/010/015/291/013
Medtronic: CareLink Programmer; CareLink Encore Programmer
October 2018
Implants, active, pacemakers
Model: 2090, 29901
MHRA reference: 2018/010/012/291/013
Medtronic (FA846): O-armTM O2 Imaging System
October 2018
X Ray, fluoroscopy systems
Model: BI70002000, BI70002000R
MHRA reference: 2018/010/015/291/021
Randox (RX3485): Evidence Operators Manual
12 October 2018
IVDs, clinical chemistry Model: RX3485
MHRA reference: 2018/010/012/601/006
Randox (RX5000): Brand
12 October 2018
IVDs, clinical chemistry
Model: RX5000
MHRA reference: 2018/010/012/601/003
SPINEART: FSCA-02-2018
08 October 2018
Spinal implants
Model: PAD-IM WT 12-S
MHRA reference: 2018/010/012/487/004
St. Jude Medical (Abbott): St. Jude Medical Infinity™ DBS System (8-Channel)
11 October 2018
Implants, active, stimulators, neuro
MHRA reference: 2018/010/011/291/003
Stephanix: SP4S, SP4S option AT, SP4S option AP
08 October 2018
X Ray, digital acquisition systems
MHRA reference: 2018/010/012/291/002