Follow @TheHPRA
Contact us
As Gaeilge
My HPRA:
Login
Register
About Us
Medicines
Veterinary
Medical Devices
Cosmetics
Controlled Substances
Blood, Tissues, Organs
Medical Devices
Safety Information
Safety communications
My HPRA:
Login
Register
About Us
Medicines
Veterinary
Medical Devices
COVID-19 Updates
Our role
Safety Information
Reporting safety issues
Monitoring device safety
Safety communications
About HPRA Safety Notices
Manufacturer's Field Safety Notices
User Engagement
Consumer advice
Regulatory Information
Registration
Medical Devices News & Events
Special Topics
Contact Medical Devices
Cosmetics
Controlled Substances
Blood, Tissues, Organs
Summary of Field Safety Notices - June 2015
Notice type:
3rd Party Publications
Date:
02/07/2015
Further Information:
Alcon
Accurus® 2500 Standalone Vitreous Probe, Accurus® 23 GA Standalone Vitreous Probe, Accurus® 25+ 2500 CPM Standalone Vitreous Probe, Anterior Accurus® Probe with Infusion Needle
Advice regarding a device removal. HPRA Ref: V24456
Argon Medical
T-Lok™ Bone Marrow Biopsy products
Advice regarding a device removal. HPRA Ref: V24602
ArthoCare Corporation / Smith & Nephew
Procise Ez View
Advice regarding a device removal. HPRA Ref: V24565
Barco
Barco Surgical Display MDSC-2224, MDSC-2226, MDSC-2242
Advice regarding a device modification. HPRA Ref: V24416
Baxter Healthcare
Flo Gard 6201 Compatible Blood Set
Advice regarding a device removal. HPRA Ref: V24670
Bedfont Scientific
NOxBOX
Advice regarding a software upgrade. HPRA Ref: V24491
BioMérieux
Etest CEFOTAXIME CT 256
Advice regarding a device removal. HPRA Ref: V24523
BVI BeaverVisitec
BVI CustomEyes® Ophthalmic Procedure Kits
Advice regarding a device removal. HPRA Ref: V24172
Covidien LLC
Puritan Bennett 980 Series Ventilator System
Advice regarding a software upgrade. HPRA Ref: V22988
Covidien LLC
Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless & Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuf
f
Advice regarding a device removal. HPRA Ref: V24258
Dräger Medical
Fabius MRI Anaesthesia Systems
Advice regarding the use of the device. HPRA Ref: V24546
Dräger Medical GmbH
Sola 500/700
Advice regarding a device modification. HPRA Ref: V24694
Edwards Lifesciences
EV1000 NI Heart Reference Sensor for the ClearSight System
Advice regarding the use of the device. HPRA Ref: V24437
Fresenius Medical Care
CRIT-LINE® Blood Chamber
Advice regarding a device removal. HPRA Ref: V24356
GE Healthcare
D-Fend/D-Fend+ Water Traps
Advice regarding a device removal. HPRA Ref: V24643
GE Healthcare
Precision 500D - Precision Rxi - Precision Mpi
Advice regarding a device modification. HPRA Ref: V24651
GE Healthcare
GE Healthcare MRI Systems
Advice regarding a software upgrade. HPRA Ref: V23893
Hoffrichter GmbH
TREND II, Point, Vector et
Advice regarding a device modification. HPRA Ref: V24419
Intuitive Surgical
da Vinci® Standard, S™ and Si™ Surgical Systems Drapes
Advice regarding the use of the device. HPRA Ref: V23812
Leonard Lang KG
ECG Electrode
Advice regarding a device removal. HPRA Ref: V23579
LifeCell Corporation
Strattice™ Reconstructive Tissue Matrix
Advice regarding the use of the device. HPRA Ref: V24646
Lohmann & Rauscher GmbH & Co. KG
Raucodrape Surgical Incise Drape, 55 x 80 cm, sterile
Advice regarding a device removal. HPRA Ref: V24484
Medline Industries
Medline Surgical Clipper Charger base
Advice regarding a device removal. HPRA Ref: V24664
Medtronic
"Medtronic DLP® Femoral Arterial Cannula Medtronic DLP® Femoral Cannula and Insertion Kit"
Advice regarding a device removal. HPRA Ref: V24502
Medtronic
Medtronic MiniMed 640G Insulin Pump. FSN 1
Medtronic MiniMed 640G Insulin Pump. FSN 2
Advice regarding changes/updates made to instructions for use. HPRA Ref: V24580
Medtronic
Medtronic Navigation Cannulated Taps
Advice regarding the use of the device. HPRA Ref: V24414
Mortara Instrument, Inc
ELI 380 electrocardiograph
Advice regarding a software upgrade. HPRA Ref: V24451
MZ Liberec
Ceiling Pendant SPR 10
Advice regarding a device modification. HPRA Ref: V24225
Nihon Kohden Corp
Central Monitor CNS-6201
Advice regarding a software upgrade. HPRA Ref: V24493
Northern Digital Inc.
Disposable Reflective Marker Spheres
Advice regarding the use of the device. HPRA Ref: V24673
One Lambda Inc.
Lambda Cell Tray™
Advice regarding a device removal. HPRA Ref: V24486
Philips Medical Systems
MobileDiagnost wDR 1 and 2
Advice regarding a device modification. HPRA Ref: V24564
Philips Medical Systems
Philips Expression MRI Patient Montoring System
Advice regarding changes/updates made to instructions for use. HPRA Ref: V24619
Richard-Allan
Mucolexx / Mucolytic Agent
Advice regarding a device removal. HPRA Ref: V24405
Roche
Sulfasalazine/Sulfapyridine-Drug Interference in ALT/ALTL/ALTLP/ALTPM, AST/ASTL/ASTLP/ASTPM, CKMBL/CKMB/CK-MB, GLDH/GLDH3, NH3/NH3L
Advice regarding the use of the device. HPRA Ref: V24469
Roche Diagnostics
"cobas b 123 FLUID PACK 200
cobas b 123 FLUID PACK 400
cobas b 123 FLUID PACK COOX 200
cobas b 123 FLUID PACK COOX 400
cobas b 123 FLUID PACK COOX 700"
Advice regarding the use of the device. HPRA Ref: V24717
Shimadzu Europa GmbH
Shimadzu Safire 17 Digital Radiographic System
Advice regarding the use of the device. HPRA Ref: V24262
Siemens
SOMATOM Emotion 6 Slice Configuration and 16 Slice Configuration.
Advice regarding a device modification. HPRA Ref: V24453
Siemens AG
Artis zee/Artis zeego
Advice regarding a device modification. HPRA Ref: V24368
Siemens Healthcare Diagnostics
IMMULITE and 1000 sample cup holders / IMMULITE 2000 microsample inserts
Advice regarding the use of the device. HPRA Ref: V24516
Siemens Healthcare GmbH
Artis Zee Floor, Artis Zee Biplane, Artis Zee Multi Purpose systems with SW version VC21B
Advice regarding a software upgrade. HPRA Ref: V24431
Siemens Medical Solutions
V5Ms Transesophageal Transducer
Advice regarding the use of the device. HPRA Ref: V23886
Smith & Nephew Orthopaedics Ltd.
Birmingham Hips Resurfacing (BHR) System
Advice regarding a device removal. HPRA Ref: V24443
Smiths Medical
Portex Bivona Inner Cannula for Bivona Adult Tracheostomy Tube
Advice regarding the use of the device. HPRA Ref: V24010
Synthes GmbH
Oscillating Saw Attachment for Colibri/Colibri II/Small Electric Drive
Advice regarding a device removal. HPRA Ref: V23989
Synthes GmbH
Pull Reduction Device for Percutaneous Drill Guide Ø 4.3mm
Advice regarding a device removal. HPRA Ref: V24575
Volcano Corporation
s5 and Core Series with software versions 3.3 and 3.4, and v3.4 software kits
Advice regarding a software upgrade. HPRA Ref: V24711
Weinmann
SOMNOventCR and prismaCR
Advice regarding the use of the device. HPRA Ref: V24554
« Back
Date Printed: 05/12/2023