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 .
Siemens Healthcare Diagnostics: Clinitek Novus
January 2015
Device description: IVDs, extra laboratory testing
Model: CLINITEK Novus Analyzer
MHRA reference:
Randox Laboratories: Beta 2 microglobulin
Device description: IVDs, immunology
Model: Beta 2 microglobulin calibrator kit (BM1362)
MHRA reference:
BrainLAB: Brainlab Offset Cup Impactor Universal
11 December 2014
Device description: Surgical instruments, implant
Model: 52856, 52856A
MHRA reference:
Randox Laboratories: Ammonia
22 January 2015
Device description: IVDs, clinical chemistry
Model: AM1015 AM1054 AM8112
MHRA reference:
Karma Mobility: Karma Atigra powered wheelchair with attendant control
December 2014
Device description: Wheelchairs, powered
MHRA reference:
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:
Intuitive Surgical: Harmonic ACER instruments 鈥� Harmonic ACER Curved Shears Insert
Device description: surgical, diathermy
Model: 00274; 400275; 420274; 420275; 400272
MHRA reference:
Siemens Healthcare Diagnostics: Clinitek Novus
Device description: IVDs, extra laboratory testing
MHRA reference:
Stryker Trauma: Teeth2322020 - Ivory Reamer 酶 11mm / 6 Teeth
23 January 2015
Device description: surgical instruments, implant
Model: 2322010 - Ivory Reamer 酶 10mm / 6 Teeth2322020 - Ivory Reamer 酶 11mm / 6 Teeth
MHRA reference:
Biosense Webster: 39E23R
16 January 2015
Device description: therapy tissue ablation
Model: 6鈥� Interface Cable
MHRA reference:
Thermo Fisher Scientific
26 January 2015
Device description: IVDs, bacteriology
Model: Oxoid Antimicrobial Susceptibility Testing Discs TIM85
MHRA reference:
Stanmore Implants Worldwide
23 January 2015
Device description: joint prosthesis, knee
Model: METS Modular Proximal Tibial Replacement
MHRA reference:
One Lambda
19 January 2015
Device description: IVDs, immunology
Model: LABType HD DRB1 Typing Test
MHRA reference:
Philips Medical Systems DMC
18 December 2014
Device description: X-ray, ancillary equipment and accessories
Model: 712027, 712028, 712029
MHRA reference:
Baxter Healthcare
January 2015
Device description: peritoneal tubing set
Model: Povidone-Iodine MiniCap, MiniCap with Povidone-Iodine
MHRA reference:
Thermo Fisher Scientific: Oxoid Legionella BCYE Growth Supplement
26 January 2015
Device description: IVDs, bacteriology
Model: Oxoid Legionella BCYE Growth Supplement (SR0110A)
MHRA reference:
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:
B Braun Medical: Biolox delta
23 January 2015
Device description: joint prosthesis, hip
Model: NH102D
MHRA reference: