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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
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Date Printed: 26/04/2024