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Summary of Field Safety Notices – September 2014
Notice type:
3rd Party Publications
Date:
02/10/2014
Further Information:
Abbott Molecular Inc
m24sp Instrument
Advice regarding changes/updates made to instructions for use - HPRA Ref: V22063
Abbott Molecular Inc
m2000sp Instrument Systems
Advice regarding a device modification - HPRA Ref: V22110
Bard
DuaLok Breast Localization Wire
Advice regarding a device removal - HPRA Ref: V21899
BioMérieux
VIDAS Anti HBs Total II
Advice regarding changes/updates made to instructions for use - HPRA Ref: V22100
Bolton Medical
Relay Plus Thoracic Stent-Graft System and Relay NBS Thoracic Stent-Graft with Plus Delivery System, 28M3 or 28N2
Advice regarding the use of the device - HPRA Ref: V21660
Cardiac Pacemaker Inc (BSC)
COGNIS CRT-D; TELIGEN DR ICD; TELIGEN VR ICD
Advice regarding a software upgrade - HPRA Ref: V22088
Covidien LLC
Puritan Bennett™ 840 Ventilator
Advice regarding changes/updates made to instructions for use - HPRA Ref: V21787
DiaMed GmbH
NaCl, Enzyme Test and Cold Agglutinins
Advice regarding a device removal - HPRA Ref: V22040
Eckert & Ziegler BEBIG GmbH
IsoStrand Brachytherapy seeds
Advice regarding the use of the device - HPRA Ref: V22030
Ethicon Endo-Surgery
Echelon Endopath Endoscopic Linear Cutter Reloads
Advice regarding the use of the device - HPRA Ref: V21992
HeartSine
Pad-Pak and Paediatric-Pak
Advice regarding a device removal - HPRA Ref: V21366
JenaValve Technology GmbH
JenaValve Cathlete Plus Delivery System - transapi
Advice regarding the use of the device - HPRA Ref: V21905
MacoPharma
MacoPharma Whole Blood Collection, Quad-Pack System
Advice regarding a device removal - HPRA Ref: V21901
Molnlycke Health Care AB
Basin Liner
Advice regarding a device removal - HPRA Ref: V22096
Origio
Double Lumen Needles for Oocyte Retrieval
Advice regarding a device removal - HPRA Ref: V21842
Ortho Clinical Diagnostics
VITROS 4600 Chemistry Systems and VITROS 5600 Integrated Systems
Advice regarding a software upgrade - HPRA Ref: V21949
Philips Healthcare
Expression Information Portal IP5
Advice regarding a software upgrade - HPRA Ref: V22024
Philips Medical Systems
MobileDiagnost wDR
Advice regarding a device modification - HPRA Ref: V22009
Schiller AG
Cardiovit AT-102 plus
Advice regarding a software upgrade - HPRA Ref: V22041
Siemens AG - Healthcare
Symbia T camera /Symbia Intevo camera systems
Advice regarding a device modification - HPRA Ref: V21779
Siemens AG / Healthcare Sector
Artis Zeego ; Artis zee / various
Advice regarding a device modification - HPRA Ref: V22109
Siemens AG / Healthcare Sector
Artis Zeego ; 10280959
Advice regarding a device modification - HPRA Ref: V22111
Siemens AG Healthcare Sector
Symbia S and T Series camera systems
Advice regarding a device modification - HPRA Ref: V21898
Siemens Healthcare Diagnostics
ADVIA Centaur HBc Total assay
Advice regarding a device removal - HPRA Ref: V22093
Siemens Healthcare Diagnostics
CLINITEK Status, CLINITEK Status+, and CLINITEK Status Connect Systems
Advice regarding a device removal - HPRA Ref: V22094
Siemens Healthcare Diagnostics
IMMULITE 2000, IMMULITE 2000XPi, VersaCell, VersaCell X3
Advice regarding the use of the device - HPRA Ref: V20024
Siemens Healthcare Diagnostics
CentraLink™ Data Management Systems
Advice regarding the use of the device - HPRA Ref: V21794
Siemens Medical Solutions USA, Inc.
E.cam and Symbia E collimator carts; 7760908,7760882
Advice regarding a device modification - HPRA Ref: V21570
Siemens Medical Solutions USA, Inc., Ultrasound Division
V5Ms transesophageal transducer #32800000-#42300000
Advice regarding the use of the device - HPRA Ref: V21820
Standard Diagnostics Inc
Panbio Q Fever lgM ELISA
Advice regarding a device removal - HPRA Ref: V22129
Stryker Medical
Stryker and Gaymar Blood / Fluid Warmer Cassettes
Advice regarding a device removal - HPRA Ref: V21878
Synovis Life Technologies
DURA-GUARD, PERI-GUARD and VASCU-GARD
Advice regarding the use of the device - HPRA Ref: V21683
Teleflex Medical
Hudson RCI Nebulizer Adaptor
Advice regarding a device removal - HPRA Ref: V21922
ThermoFisher Scientific
Oxoid Listeria Latex Kit
Advice regarding a device removal - HPRA Ref: V21784
TriVascular, Inc.
Ovation Prime Abdominal Stent Graft System
Advice regarding a device removal - HPRA Ref: V22071
Urotech GmbH
Guide Wire Semislip UAS-35150–SS
Advice regarding a device removal - HPRA Ref: V22115
Vision-Sciences Inc.
Vision Sciences® Battery Charger and Rechargeable Lithium-Ion Batteries
Advice regarding a device removal - HPRA Ref: V21752
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Date Printed: 26/04/2024