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Summary of Field Safety Notices - March 2017
Notice type:
3rd Party Publications
Date:
04/04/2017
Further Information:
Abbott - Thoratec Corporation
HeartMate II System Controller
Advice regarding a software upgrade. HPRA Ref: V31358
Abbott Vascular
NC Trek RX Coronary Dilatation Catheter, NC Traveler RX Coronary Dilatation Catheter, NC Tenku RX PTCA Balloon Catheter
Advice regarding a device removal. HPRA Ref: V31239
Aesculap AG
Diamond burrs
Advice regarding a device removal. HPRA Ref: V31344
Baxter Healthcare
Prismaflex 6.10 Row and Prismaflex 7.XX Row
Advice regarding a software upgrade. HPRA Ref: V31035
Bbraun
Dialog iQ HDF comfort Dialysis Machines
Advice regarding a device modification. HPRA Ref: V31172
Biomerieux S.A.
ETEST® OX 256 (OXACILLIN) Foam packaging
Advice regarding the use of the device. HPRA Ref: V31349
Boston Scientific
Lotus™ Valve System
Advice regarding a device removal. HPRA Ref: V30925
Bühlmann Laboratories AG
BÜHLMANN CALEX® Cap
Advice regarding the use of the device. HPRA Ref: V31062
Carefusion
MANOMETER TRAY
JAMSHIDI NEEDLE BIOPSY
ILLINOIS (TJ) NEEDLE ASPIRATION
JAMSHIDI (TJ) NEEDLE BONE MARROW
THORACENTESIS/PARACENTESIS KIT
Advice regarding a device removal. HPRA Ref: V31147
Cook Medical
Zenith Alpha™ Thoracic Endovascular Graft
Advice regarding changes/updates made to instructions for use. HPRA Ref: V31256
Dräger Medical Systems, Inc.
Infinity® Delta, Delta XL and Kappa with SW VF10.0
Advice regarding the use of the device. HPRA Ref: V31240
Ella-CS
SX-ELLA Stent Danis Procedure Pack
Advice regarding changes/updates made to instructions for use. HPRA Ref: V30875
Endologix
Nellix Endovascular Aortic Sealing System
Advice regarding changes/updates made to instructions for use. HPRA Ref: V29719
Fannin L.I.P.
Selenite Broth 20ml
Advice regarding a device removal. HPRA Ref: V31267
GE Healthcare
Vivid E80 / E90 / E95 / S60N / S70N & Vivid S60 / S70
Advice regarding the use of the device. HPRA Ref: V31341
Hitachi High-Technologies Cooperation & Roche.
PROBE SAMPLE – cobas c. FSN 1
PROBE SAMPLE – cobas c. Attachment 1
PROBE SAMPLE – cobas c. Attachment 2
PROBE SAMPLE – cobas c. Attachment 3
PROBE SAMPLE – cobas c. FSN 2
PROBE SAMPLE – cobas c. Attachment 4
Advice regarding a device removal. HPRA Ref: V31066
Immucor
Panocell®-20
Advice regarding the use of the device. HPRA Ref: V31001
Intersurgical LIMITED
F Solus, Flexible Wire Reinforced Laryngeal Mask, sizes 2, 2.5, 3, 4 and 5
Advice regarding a device removal. HPRA Ref: V31336
Intuitive Surgical
da Vinci® Xi EndoWrist Stapler Release Kit
Advice regarding the use of the device. HPRA Ref: V31278
Lifetech Scientific
Lifetech IrisFIT™ Patent Foramen Ovale (PFO) Occluders
Advice regarding a device removal. HPRA Ref: V31112
Medtronic
Covidien Curity Sodium Chloride Dressing; Covidien Curity Eye Pad Oval
Advice regarding a device removal. HPRA Ref: V31033
Medtronic
Endurant™ / Endurant II ™ 23mm and 25mm Bifurcated Stent Graft Systems
Advice regarding a device removal. HPRA Ref: V30965
Merit Medical
Merit PreludeSYNC™ Radial Compression Device
Advice regarding a device removal. HPRA Ref: V31162
Newdeal SAS
PANTA and PANTA XL Nails
Advice regarding a device removal. HPRA Ref: V31029
PCO Manufacturing
Freestyle Lite Test Strips
Advice regarding a device removal. HPRA Ref: V30927
Philips Healthcare
HeartStart MRx Defibrillator/Monitor
Advice regarding the use of the device. HPRA Ref: V31175
Philips Healthcare
Allura Xper, Allura CV20 and UNIQ X-ray Systems
Advice regarding a device modification. HPRA Ref: V31386
Protek Medical Products Inc.
Sterile Disposable Endocavity Needle Guide
Advice regarding a device removal. HPRA Ref: V31241
ROHO
ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready™ Technology; ROHO® MID PROFILE® Single Compartment Cushion with Sensor Ready™ Technology
Advice regarding the use of the device. HPRA Ref: V31173
Schaerer Medical AG
Arcus 501, 601, 701 Surgical Table
Advice regarding a device modification. HPRA Ref: V31339
Siemens
18L6 HD transducer on the ACUSON S Family ultrasound systems
Advice regarding a software upgrade. HPRA Ref: V31383
Siemens Healthineers
AX058/16/S
Advice regarding changes/updates made to instructions for use. HPRA Ref: V30780
Smith & Nephew
Secura Protective Cream Z10 78g (CE)
Advice regarding a device modification. HPRA Ref: V30697
Smith & Nephew
VERSAJET II Hydrosurgery System Console
Advice regarding a device removal. HPRA Ref: V31331
Stryker
Stryker SmartLife Large Aseptic Housings
Advice regarding the use of the device. HPRA Ref: V31195
Tem Innovations GmbH
r-EXTEM Assay for ROTEM® delta Thromboelastometry System
Advice regarding a device removal. HPRA Ref: V31199
Topcon Medical Laser Systems Inc
PASCAL Synthesis and PASCAL Synthesis TwinStar
Advice regarding a software upgrade. HPRA Ref: V29170
Trinity Biotech
Uni-Gold, H. Pylori Rapid Antigen Test
Advice regarding a device removal. HPRA Ref: V31023
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Date Printed: 18/04/2024