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Summary of Field Safety Notices - January 2015
Notice type:
3rd Party Publications
Date:
04/02/2015
Further Information:
ArthroCare Corp.
Ambient HipVac 50 wand & K-vac wands
Advice regarding a device removal. HPRA Ref: V22596
Aspide Medical
Endorec medical devices (reference MTERPACK)
Advice regarding a device removal. HPRA Ref: V22839
Baxter Healthcare
COLLEAGUE Pump vP1.7
Advice regarding the use of the device. HPRA Ref: V22998
Baxter Healthcare
MiniCap with Povidone-Iodine Solution
Advice regarding a device removal. HPRA Ref: V23183
Baxter Healthcare AG
EasySpray, Tissomat and DuploSpray Pressure Regulators
Advice regarding a device removal. HPRA Ref: V23143
Carestream Health Inc.
CS 8100 and CS 8100 3D Dental X-ray Equipment
Advice regarding a device modification. HPRA Ref: V23006
Chiltern Invadex Limited
OHCB2-000 & OHCB3-000 Hoist Spreader Bars
Advice regarding a device removal. HPRA Ref: V22935
Clinical Innovations
Ebb Complete Tamponade System (CTS-1000)
Advice regarding a device removal. HPRA Ref: V22984
Gambro Dasco S.p.A.
Artis/Evosys machines equipped or upgraded to sw. revision 8.09.12; 8.09.13; 8.15.06; 8.33.02
Advice regarding the use of the device. HPRA Ref: V22958
Gambro Dasco S.p.A.
Artis/Evosys machine equipped or upgraded to sw. revision 8.15.06; 8.33.02
Advice regarding changes/updates made to instructions for use. HPRA Ref: V23024
Immucor GTI Diagnostics Inc.
PF4 Enhanced, PF4 IgG or PF4 Concentrated Wash
Advice regarding a device removal. HPRA Ref: V23005
Inmed
551.31 Filtraflux + Softflex, 551.33 Hepa Filter Humidifier + Softflex and various other devices mentioned in Appendix 1
Advice regarding a device removal. HPRA Ref: V22920
Karma Mobility
Karma Atigra powered wheelchair with attendant control
Additional Attachment
Advice regarding a device modification. HPRA Ref: V23101
Maquet
MAQUET CARDIOSAVE® Hybrid Intra-Aortic Balloon Pump
Advice regarding a device modification. HPRA Ref: V22934
Maquet
Demonstration SENSATION 7 Fr. intra-Aortic Balloon Catheter (IABC), Demonstration SENSATION PLUS 7.5 Fr. and 8 FR. IABC
Advice regarding the use of the device. HPRA Ref: V22954
Medtronic
InterStim®, InterStim® II, Itrel®3 and Enterra®
Advice regarding the use of the device. HPRA Ref: V22994
Navilyst Medical Inc.
Xcela™ PICC & BioFlo™ PICC
Advice regarding a device removal. HPRA Ref: V23042
Oy Medix Biochemica Ab
Actim Partus test
Advice regarding the use of the device. HPRA Ref: V22804
ParkHouse Healthcare
Phase III mattresses and Richmond Ultra Low bed
Advice regarding a device modification. HPRA Ref: V22693
Philips Healthcare
Philips Anaesthesia machines - Various
Advice regarding a device modification. HPRA Ref: V22914
Philips Healthcare
Philips Anaesthesia machines - Various
Advice regarding a device modification. HPRA Ref: V22917
Philips Healthcare
Philips HeartStart MRx Monitor/Defibrillator
Advice regarding a software upgrade. HPRA Ref: V22933
Philips Healthcare
DigitalDiagnost
Advice regarding a software upgrade. HPRA Ref: V23258
Q Core Medical
Microbore Administration sets: AP403 and AP424
Advice regarding a device removal. HPRA Ref: V22216
Radiometer
ABL90 FLEX Analyser
Advice regarding the use of the device. HPRA Ref: V22906
Radiometer Limited
942-063 pCO2 Membrane Box (D788) used with ABL700 and ABL800 Series Analysers
Advice regarding a device modification. HPRA Ref: V18292
Siemens
Digital Linear Accelerators of type MEVATRON, PRIMUS, ONCOR and ARTISTE
Advice regarding the use of the device. HPRA Ref: V22697
Siemens
Digital Linear Accelerators of type MEVATRON, PRIMUS, ONCOR and ARTISTE
Advice regarding a device modification. HPRA Ref: V22924
Siemens
RAPIDPoint® 405/500 Systems and RAPIDLab® 1245/1265 Systems
Advice regarding the use of the device. HPRA Ref: V22976
Siemens AG Healthcare
syngo.plaza
Advice regarding a software upgrade. HPRA Ref: V23078
Siemens AG Healthcare
Artis Q ceiling and Artis.zen ceiling systems
Advice regarding a device modification. HPRA Ref: V22682
Siemens Healthcare
LANTIS TM Oncology Information System Server
Advice regarding the use of the device. HPRA Ref: V23090
Siemens Healthcare Diagnostics
ADVIA Centaur Systems Progesterone
Advice regarding the use of the device. HPRA Ref: V23274
Smith & Nephew Orthopaedics
BIRMINGHAM HIP™ Resurfacing System (BHR)
Advice regarding changes/updates made to instructions for use. HPRA Ref: V23019
Smiths Medical
Omnifuse UK Mains Power Leads
Advice regarding the use of the device. HPRA Ref: V22083
Sony
Sony LMD-1951MD Monitors
Advice regarding a device modification. HPRA Ref: V23002
Teleflex
Curved Reinforced Tracheal Tubes - Various
Advice regarding the use of the device. HPRA Ref: V22624
Thermofisher Scientific
Oxoid Legionella BCYE Growth Supplement, SR0110A
Advice regarding a device removal. HPRA Ref: V23178
TRUMPF Medical Systems
JUPITER / ARTIS / TruSystem 7500 Operating Table
Advice regarding a device modification. HPRA Ref: V23011
Zimmer
Various Sterile Packaged Femoral Heads and Tapers
Advice regarding a device removal. HPRA Ref: V23003
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Date Printed: 15/08/2022