Field safety notices - 12 to 16 January 2015
Read the official alert on GOV.UK — MedRegWatch re-presents it; GOV.UK is the authoritative source.
| Type | Field safety notice (devices) |
|---|---|
| Issued | 16 Jan 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