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