Field safety notices - 26 to 30 January 2015
List of field safety notices (FSNs) from medical device manufacturers from 26 to 30 January 2015.
You can see copies of field safety notices in our filecamp folder.
Siemens Healthcare Diagnostics: Clinitek Novus
January 2015
Device description: IVDs, extra laboratory testing
Model: CLINITEK Novus Analyzer
MHRA reference: 2015/001/023/601/001
Randox Laboratories: Beta 2 microglobulin
Device description: IVDs, immunology
Model: Beta 2 microglobulin calibrator kit (BM1362)
MHRA reference: 2014/010/030/601/004
BrainLAB: Brainlab Offset Cup Impactor Universal
11 December 2014
Device description: Surgical instruments, implant
Model: 52856, 52856A
MHRA reference: 2015/001/015/701/001
Randox Laboratories: Ammonia
22 January 2015
Device description: IVDs, clinical chemistry
Model: AM1015 AM1054 AM8112
MHRA reference: 2015/001/022/601/004
Karma Mobility: Karma Atigra powered wheelchair with attendant control
December 2014
Device description: Wheelchairs, powered
MHRA reference: 2015/001/026/071/006
Molnlycke Health Care: Emergency Chest Re-opening Pack Cardiothoracic surg proc kit, non-med, single use
22 January 2015
Device description: Surgical instruments, articulated retracting
Model: Emergency Chest Re-opening Pack - 97039083-00
MHRA reference: 2015/001/023/181/002
Intuitive Surgical: Harmonic ACER instruments • Harmonic ACER Curved Shears Insert
Device description: surgical, diathermy
Model: 00274; 400275; 420274; 420275; 400272
MHRA reference: 2015/001/027/131/004
Siemens Healthcare Diagnostics: Clinitek Novus
Device description: IVDs, extra laboratory testing
MHRA reference: 2015/001/027/601/002
Stryker Trauma: Teeth2322020 - Ivory Reamer ø 11mm / 6 Teeth
23 January 2015
Device description: surgical instruments, implant
Model: 2322010 - Ivory Reamer ø 10mm / 6 Teeth2322020 - Ivory Reamer ø 11mm / 6 Teeth
MHRA reference: 2015/001/021/081/020
Biosense Webster: 39E23R
16 January 2015
Device description: therapy tissue ablation
Model: 6’ Interface Cable
MHRA reference: 2013/007/001/081/020
Thermo Fisher Scientific
26 January 2015
Device description: IVDs, bacteriology
Model: Oxoid Antimicrobial Susceptibility Testing Discs TIM85
MHRA reference: 2015/001/028/601/005
Stanmore Implants Worldwide
23 January 2015
Device description: joint prosthesis, knee
Model: METS Modular Proximal Tibial Replacement
MHRA reference: 2015/001/007/081/024
One Lambda
19 January 2015
Device description: IVDs, immunology
Model: LABType HD DRB1 Typing Test
MHRA reference: 2015/001/028/071/007
Philips Medical Systems DMC
18 December 2014
Device description: X-ray, ancillary equipment and accessories
Model: 712027, 712028, 712029
MHRA reference: 2015/001/029/071/010
Baxter Healthcare
January 2015
Device description: peritoneal tubing set
Model: Povidone-Iodine MiniCap, MiniCap with Povidone-Iodine
MHRA reference: 2015/001/029/131/004
Thermo Fisher Scientific: Oxoid Legionella BCYE Growth Supplement
26 January 2015
Device description: IVDs, bacteriology
Model: Oxoid Legionella BCYE Growth Supplement (SR0110A)
MHRA reference: 2015/001/027/601/001
Rayner Intraocular Lenses
C-flex Aspheric, C-flex Aspheric with RaySert PLUS, M-flex, T-flex Aspheric, Sulcoflex Aspheric Superflex Aspheric and Superflex Aspheric with RaySert PLUS
26 January 2015
Device description: implants, non-active, intraocular
Model: 970C, RSP970C, 630F, 573T, 632T, 653L, 920H and RSP920H
MHRA reference: 2015/001/029/601/003
B Braun Medical: Biolox delta
23 January 2015
Device description: joint prosthesis, hip
Model: NH102D
MHRA reference: 2015/001/029/131/006