Field safety notices - 12 to 16 January 2015

List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 January 2015.

You can see copies of field safety notices in our filecamp folder.

Audit Diagnostics: direct bilirubin vanadate

6 March 2013

Device description: IVDs, clinical chemistry

Part numbers: AD2035BR, ADM2035 and AUD2525.

MHRA reference: 2015/001/008/081/017

Audit Diagnostics: salicylate enzymatic reagent kit

16 August 2014

Device description: IVDs, clinical chemistry

Catalogue number: OAR6910 Part number: B1994 Lot number: 8615. FSN dated 16 August 2014

MHRA reference: 2015/001/013/081/004

Baxter Healthcare: vP1.7 Colleague pump

January 2015

Device description: Infusion systems, electrically powered infusion pump

Product code: 2M81517K, 2M81537K, 2M91617 and 2M91637 All serial numbers

MHRA reference: 2015/001/014/081/010

Brahms (part of ThermoFisher Scientific): B-RAH•M•S NSE KRYPTOR

5 January 2015

Device description: IVDs, clinical chemistry

Lot number: 21048A

MHRA reference: 2015/001/006/081/024

Carestream Health: CS 8100 and CS 8100 3D

5 January 2015

Device description: X-ray, dental imaging, digital detector

MHRA reference: 2015/001/013/081/005

Clinical Innovations: Ebb complete tamponade system (CTS-l000)

5 January 2015

Device description: surgical instruments, minimal access

Lot numbers: 0314-F-566; 0814-F-100; 0814-F-108; 0814-V-068

MHRA reference: 2015/001/009/081/053

Gambro Dasco: Artis/Evosys dialysis machines

Device description: haemodialysis

Manufacturer reference: FA-2014-010

MHRA ref: 2014/012/029/081/002

GTI Diagnostics: PF4 enhanced and PF4 IgG

15 December 2014

Device description: Coagulation

MHRA reference: 2015/001/012/701/008

Invacare: PerfectO2™ and Platinum® concentrator

12 January 2015

Device description: Oxygen concentrators

Manufacturer reference: FSN 82590 amendment

MHRA reference: 2014/011/019/081/015

Medtronic: InterStim®, InterStim® II, Itrel®3 and Enterra®

9 January 2015

Device description: implants, active, stimulators, neuro, pain control - spinal cord

MHRA reference: 2015/001/009/081/004

Medtronic MiniMed: 640G system

12 January 2015

Device description: infusion systems, ambulatory insulin infusion pump

Model: MMT-1511, MMT-1512. Bolus delivery accuracy

MHRA reference: 2015/001/009/081/051

Otto Bock Healthcare

16 December 2014

Device description: Wheelchairs, powered, frame

Product codes: B500, B500-S, B600 and C1000-DS powered wheelchairs, B500, 490E32=00000_C; B500-S, 490E32=60000_K; B600, 490E32=10000_K; C1000-DS, 490E68=00000_K

MHRA reference: 2015/001/012/081/020

Q Core: AP424 , AP403

January 2015

Device description: infusion and transfusion, administration sets, extension set

MHRA reference: 2014/010/009/081/004

Roche Diagnostics: cobas® KRAS mutation kit

18 December 2014

Device description: IVDs, viral microbiology

Lot number: T10786

MHRA reference: 2014/012/023/081/040

Siemens : syngo.plaza

14 October 2014

Device description: Picture archiving and communication system (PACS)

MHRA reference: 2014/012/011/601/013

Sony Corporation: SONY LMD-1951MD monitors

14 January 2015

Device description: Standalone diagnostic workstation

MHRA reference: 2015/001/013/081/003

STERIS: STERIS PTX, PTX+, vex, and UCX+ endoscope reprocessors

12 January 2015

Device description: CSSD wash/clean/drying equipment

MHRA reference: 2015/001/013/081/009

Stryker Instruments: Battery - SmartLife™ small / large aseptic housings

23 October 2014

Device description: Surgical power tools

MHRA reference: 2014/010/017/081/007

Synthes: 397.232

15 December 2014

Device description: Surgical instruments, implant, retractor

MHRA reference: 2014/012/030/081/004

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