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

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