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. FSN 2
PROBE SAMPLE - cobas c. FSN 3
PROBE SAMPLE - cobas c. FSN 4
PROBE SAMPLE - cobas c. FSN 5
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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