Field safety notices - 3 to 7 August 2015
List of field safety notices (FSNs) from medical device manufacturers from 3 to 7 August 2015.
Overview
If you receive a field safety notice (FSN) from a manufacturer you must always act on it.
MHRA publishes the following for information only.
If you have a question about a particular FSN contact the manufacturer.
Latest FSNs
Arrow International: catheter, central venous, Arrow庐 International PICC kits with peel-away sheath component
31 July 2015
Vascular cannula and catheters
MHRA reference:
Beckman Coulter: access thyroglobulin assay
4 August 2015
IVDs, clinical chemistry
MHRA reference:
Becton Dickinson: BBL CHROMagar MRSA II
5 August 2015
IVDs, bacteriology
Model: 257434 / 257435 / 257585
MHRA reference:
Bedfont Scientific: NOxBOXi
23 July 2015
Lung ventilators
MHRA reference:
Biocartis: Idylla鈩� KRAS mutation test
04 August 2015
IVDs, viral microbiology
MHRA reference:
Biomerieux: Vitek庐 2 antimicrobial susceptibility test kit (AST-YS01, AST-YS06, AST-YS07) 22108, 412610, 414967
20 April 2015
IVDs, bacteriology
MHRA reference:
Carestream Health: DRX Evolution Systems w/premium and FF wall stand
3 August 2015
X-ray, digital acquisition systems
MHRA reference
Depuy Synthes: battery oscillator II, handpiece
29 July 2015
Surgical power tools
Model: 530.710
MHRA reference:
Depuy Synthes: surgical screw driver
31 July 2015
Surgical instruments, implant
Model: 356.714
MHRA reference:
Depuy Synthes: VEPTR庐 vertical expandable prosthetic titanium rib caudal rib supports
29 July 2015
Spinal implants
MHRA reference:
Gainsborough Bathrooms: baths
August 2015
Bath and aids
Model: Ascot TS
MHRA reference:
GE Medical Systems: GE MR Systems
4 August 2015
Magnetic resonance, equipment & accessories
MHRA reference:
Insulet Corporation: OmniPod庐 insulin management system
14 July 2015
Infusion systems
MHRA reference:
JOTEC: E-tegra stent graft system
27 July 2015
Implants, non-active, endoprostheses for aortic aneurysms
MHRA reference:
Leica Biosystems: ASP6025 tissue processor
29 July 2015
IVDs, cytopathology & histopathology
MHRA reference:
Philips Medical Systems: Digital Diagnost
19 June 2015
X-ray, digital acquisition systems
Model: 712031, 712032, 712033
MHRA reference:
Roche Diagnostics: cobas庐 6800 system, cobas庐 8800 system
23 July 2015
IVDs, viral microbiology
Model: 05524245001, 05412722001
MHRA reference:
Siemens Healthcare Diagnostics: RAPIDPoint 500
July 2015
IVDs, extra laboratory testing
MHRA reference:
Siemens Healthcare Diagnostics: ADVIA Centaur XPT
July 2015 (CSW-15-03)
IVDs, clinical chemistry
MHRA reference:
Theraclion: Echopulse
20 July 2015
Ultrasound, therapy
Model: THC800154-D and THC800154-E
MHRA reference:
Vygon: NS2 20ML syringe
05 August 2015
Feeding systems and tubes
Model: 1015202
MHRA reference:
Vygon
31 July 2015
Injection devices
Model: 0P6193115PHA, 0P6193253PHA, 0P6193254PHA, 0P0199848PHA, 0P0199951PHA, 0P01991528PHA, 0P01992217PH
MHRA reference: