My HPRA: Register

Summary of Field Safety Notices - May 2016

Notice type: 3rd Party Publications

Date: 02/06/2016

  

Further Information:
Abbott Laboratories
CELL-DYN Emerald Cleaner
Advice regarding a device removal. HPRA Ref: V27331


Alcon Laboratories, Inc
CENTURION® FMS Pack for CENTURION® Vision System
Advice regarding a device removal. HPRA Ref: V27679


Alphadent NV
Ceka-Precilline - English FSN
Ceka-Precilline - Irish FSN
Advice regarding a device removal. HPRA Ref: V27674


Baxter Healthcare SA
Vivia System
Advice regarding a device removal. HPRA Ref: V27930


Beckman Coulter
Enzymatic Creatinine, OSR6X204; Cholesterol, OSR6X16; Triglyceride OSR6X118; Uric Acid, OSR6X98; Lactate, OSR6X93; Lipase, OSR6X30; HDL Cholesterol, OSR6X87
Advice regarding changes/updates made to instructions for use. HPRA Ref: V27556


Beckman Coulter
ALT OSR6X07 & Glucose-Stat OSR6X40
Advice regarding changes/updates made to instructions for use. HPRA Ref: V27814


BioFire Diagnostics
BCID kits
Advice regarding the use of the device. HPRA Ref: V27667


bioMérieux SA
ADENOVIRUS R-gene KIT®, BK VIRUS R-gene KIT®, HSV1 HSV2 VZV R-gene KIT®, QUANTI FluA QS r-gene®, QUANTI HHV8 QS r-gene®, HHV6 Premix r-gene®, HHV7 Premix r-gene®, HHV8 Premix r-gene®, CELL Control r-gene®, PARECHOVIRUS r-gene®, HCoV/PIV r-gene®, HSV1 r-gene®, HSV2 r-gene®, VZV r-gene® FSN 1

ADENOVIRUS R-gene KIT®, BK VIRUS R-gene KIT®, HSV1 HSV2 VZV R-gene KIT®, QUANTI FluA QS r-gene®, QUANTI HHV8 QS r-gene®, HHV6 Premix r-gene®, HHV7 Premix r-gene®, HHV8 Premix r-gene®, CELL Control r-gene®, PARECHOVIRUS r-gene®, HCoV/PIV r-gene®, HSV1 r-gene®, HSV2 r-gene®, VZV r-gene® FSN 2
Advice regarding the use of the device. HPRa Ref: V27760


bioMérieux SA
chromID MRSA SMART
Advice regarding a device removal. HPRA Ref: V27890


Biomet Orthopaedics
M2a 38mm Acetabular System
Advice regarding the review of patient results/patient recall/sample retesting is required. HPRA Ref: V27535


Biosense Webster
Pentaray® Nav Catheter; Pentaray® Nav Eco Catheter
Advice regarding changes/updates made to instructions for use. HPRA Ref: V27516


Carestream Health Inc.
Image Suite 3.0 with Mini-PACS Options and Hot Fix 3004 software patch & Image Suite 4.0 with Mini-PACS and DICOM Store
Advice regarding a software upgrade. HPRa Ref: V27572


Carl Zeiss
IOL Master 500
Advice regarding a software upgrade. HPRA Ref: V26125


ConMed Corporation
"ThermoGard® Dual Dispersive Electrodes May"
Advice regarding a device removal. HPRA Ref: V27902


Cook Ireland Limited
FluoroSet® Radiographic Tubal Assessment Set; Selective Salpingography Catheter with Beacon® Tip; Kumpe Access Catheter
Advice regarding a device removal. HPRA Ref: V27533


Cordis Corporation
Cordis PRECISE ® PRO RX Nitinol Stent System (Carotid)
Advice regarding a device removal. HPRA Ref: V27581


Drägerwerk AG & Co. KGaA
D-Vapor; D-Vapor 3000
Advice regarding the use of the device. HPRA Ref: V27450


Drägerwerk AG & Co. KGaA
VentStar Oxylog3000F (P) 190
Advice regarding a device removal. HPRA Ref: V27943


Edwards Lifesciences
Edwards Commander Delivery System Models 9610TF23, 9610TF26, 9610TF29
Advice regarding the use of the device. HPRA Ref: V27886


Focus Diagnostics
Simplexa HSV 1 & 2 Direct, Simplexa Flu A/B & RSV Direct, Simplexa Group A Strep Direct
Advice regarding the use of the device. HPRA Ref: V27033


Intuitive Surgical
"da Vinci Xi 5 mm-8 mm Universal Seal (PN 470361) and da Vinci Xi 12mm & Stapler Universal Seal (PN 470380)"
Advice regarding the use of the device. HPRA Ref: V27799

Invacare Deutschland GmbH
FOX wheelchair
Advice regarding a device modification. HPRA Ref: V27608

  
Leica Biosystemes
Aperio eSlide Manager Software
Advice regarding a software upgrade. HPRA Ref: V27633


LifeCell
Strattice™ Reconstructive Tissue Matrix
Advice regarding changes/updates made to instructions for use. HPRA Ref: V24646


Maquet
MEGA® and SENSATION PLUS® IAB Catheters
Advice regarding changes/updates made to instructions for use. HPRA Ref: V27802


Maquet
Updated FSN: Maquet CARDIOSAVE® Hybrid Intra-Aortic Balloon Pump
Advice regarding a device modification. HPRA Ref: V26504

  
Medicina
Silo Bags - SB03, SB04, SB05, SB06, SB35 and SB45
Advice regarding a device removal. HPRA Ref: V27769


Medtronic Inc.
RestorSensor Multi-Program Rechargable Neurostimulator Restore Sensor SureScan MRI
Advice regarding the use of the device. HPRA Ref: V27660


Medtronic Inc.
Activa PC Neurostimulator, Activa SC Multi-program Neurostimulator, Activa PC+S, Activa RC Multi-Program Rechargable Neurostimulator, Soletra and Kinetra
Advice regarding changes/updates made to instructions for use. HPRA Ref: V27816


Medtronic Inc.
Capnostream™20 and Capnostream™20p Patient Monitors
Advice regarding a device modification. HPRA Ref: V27555
  

Novus Scientific
TIGR® Matrix Surgical Mesh
Advice regarding the use of the device. HPRA Ref: V27764


Olerup SSP AB
Olerup SSP HLA A typing kits: A*10 Lots: 41V 35X, 83Y / A*24 Add-on Lot: 32Y
Advice regarding a device removal. HPRA Ref: V27805


One Lambda
All Set Gold SSP Kits
Advice regarding the review of patient results/patient recall/sample retesting is required. HPRA Ref: V27918

PCO Manufacturing
Glucomen LX Sensor Test Strips
Advice regarding changes/updates made to instructions for use. HPRA Ref: V27874


Pentax Medical
ED-3490TK Video Duodenoscope
Advice regarding changes/updates made to instructions for use. HPRA Ref: V27872


Philips Healthcare
Philips MX 16-slice CT x-ray System
Advice regarding a software upgrade. HPRA Ref: V27726


Philips Medical Systems
DigitalDiagnost Upgrade Release 4.04, 4.1.2, 4.1.3
Advice regarding a software upgrade. HPRA Ref: V27731


Philips Medical Systems (Cleveland) Inc.
Brilliance 64, Ingenuity CT and Philips Brilliance iCT
Advice regarding a software upgrade. HPRA Ref: V27597


Randox Laboratories Limited
Immunoassay Control IA2640 lot 1364EC and Immunoassay Premium Plus Control IA3112 batch 334337 lot 1364EC
Advice regarding a device modification. HPRA Ref: V27708

  
Roche Diagnostics
ONLINE TDM Vancomycin 100 tests, ONLINE TDM Vancomycin 200 tests, HITACHI VANCOMYCIN (911, 912, 917, P), HITACHI VANCOMYCIN (917, P)
Advice regarding changes/updates made to instructions for use. HPRA Ref: V27896


Roche Diagnostics
ONLINE TDM Gentamicin 100 Tests c 311, c 501/502, ONLINE TDM Gentamicin 100 Tests c 701/702, ONLINE TDM Gentamicin Mod P
Advice regarding the use of the device. HPRA Ref: V27920


Siemens
TnI-Ultra (100 tests), TnI-Ultra (500 tests)
Advice regarding the use of the device. HPRA Ref: V27723


Siemens 
Dimension Enzyme II Calibrator
Advice regarding the use of the device. HPRA Ref: V27791


Smith & Nephew Orthopaedics Limited
BIRMINGHAM HIP™ RESURFACING Extraction Kit (instrument)
Advice regarding a device removal. HPRa Ref: V27455


Smiths Medical
CADD® Administration Sets with Flow Stop Free-Flow Protection
Advice regarding the use of the device. HPRA Ref: V27695


Sysmex
FLUOROCELL PLT
Advice regarding a device removal. HPRA Ref: V27967


Tem Innovations GmbH
ROTEM Platelet Cuvettes, 200188
Advice regarding a device removal. HPRA Ref: V27642


Terumo
Terumo® Destination® Guiding Sheath
Advice regarding a device removal. HPRA Ref: V27649


Tosoh Europe N.V.
Automated Enzyme Immunoassay System AIA-1800ST / AIA - 1800LA, AIA-200 ST, AIA 2000 LA
Advice regarding the use of the device. HPRA Ref: V27675


VBM Medizintechnik GmbH
Laryngeal-Tube LTS-D / size 2, single use, sterile
Advice regarding the use of the device. HPRA Ref: V27683


Volcano Corporation
SW V 3.2.x, 3.3, 3.4 on S5/Core
Advice regarding a software upgrade. HPRA Ref: V27709


Xenios AG
deltastream MDC, i-cor and ILA activve consoles
Advice regarding the use of the device. HPRA Ref: V27070

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