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 .
Audit Diagnostics: direct bilirubin vanadate
6 March 2013
Device description: IVDs, clinical chemistry
Part numbers: AD2035BR, ADM2035 and AUD2525.
MHRA reference:
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:
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:
Brahms (part of ThermoFisher Scientific): B-RAH鈥鈥 NSE KRYPTOR
5 January 2015
Device description: IVDs, clinical chemistry
Lot number: 21048A
MHRA reference:
Carestream Health: CS 8100 and CS 8100 3D
5 January 2015
Device description: X-ray, dental imaging, digital detector
MHRA reference:
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:
Gambro Dasco: Artis/Evosys dialysis machines
Device description: haemodialysis
Manufacturer reference: FA-2014-010
MHRA ref:
GTI Diagnostics: PF4 enhanced and PF4 IgG
15 December 2014
Device description: Coagulation
MHRA reference:
Invacare: PerfectO2鈩� and Platinum庐 concentrator
12 January 2015
Device description: Oxygen concentrators
Manufacturer reference: FSN 82590 amendment
MHRA reference:
Medtronic: InterStim庐, InterStim庐 II, Itrel庐3 and Enterra庐
9 January 2015
Device description: implants, active, stimulators, neuro, pain control - spinal cord
MHRA reference:
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:
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:
Q Core: AP424 , AP403
January 2015
Device description: infusion and transfusion, administration sets, extension set
MHRA reference:
Roche Diagnostics: cobas庐 KRAS mutation kit
18 December 2014
Device description: IVDs, viral microbiology
Lot number: T10786
MHRA reference:
Siemens : syngo.plaza
14 October 2014
Device description: Picture archiving and communication system (PACS)
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Sony Corporation: SONY LMD-1951MD monitors
14 January 2015
Device description: Standalone diagnostic workstation
MHRA reference:
STERIS: STERIS PTX, PTX+, vex, and UCX+ endoscope reprocessors
12 January 2015
Device description: CSSD wash/clean/drying equipment
MHRA reference:
Stryker Instruments: Battery - SmartLife鈩� small / large aseptic housings
23 October 2014
Device description: Surgical power tools
MHRA reference:
Synthes: 397.232
15 December 2014
Device description: Surgical instruments, implant, retractor
MHRA reference: