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Summary of Field Safety Notice – February 2017
Notice type:
3rd Party Publications
Date:
02/03/2017
Further Information:
Abbott Vascular
StarClose SE Vascular Closure System
Advice regarding a device removal. HPRA Ref: V30783
Acumed
Acumed 045" X 6" ST & 054" X 7" ST Guide Wire
Advice regarding a device removal. HPRA Ref: V30951
Bausch & Lomb Incorporated - USA
LASEREDGE Trapezoidal Knife
Advice regarding a device removal. HPRA Ref: V30886
Becton Dickonson and company
BD Vacutainer® SST™ II Advance Plus Blood Collection Tubes
Advice regarding a device removal. HPRA Ref: V30971
Beldico SA
Sterile disposable feeding bottles, Sterile disposable breast milk collector sets
Advice regarding a device removal. HPRA Ref: V30855
BES Corporate
Stealth Flip Down Stems
Advice regarding the use of the device. HPRA Ref: V30800
bioMerieux
VITEK® MS Instrument
Advice regarding the use of the device. HPRA Ref: V30973
CareFusion
Alaris Plus Syringe Pump
Advice regarding the use of the device. HPRA Ref: V30881
Codman Neuro
Codman Microcoil Delivery Systems and Detachment Control Boxes
Advice regarding a device removal. HPRA Ref: V30776
Cook Medical
Check-Flo Hemostasis Assembly, Flexor Radial Access Sheaths, TriForce Peripheral Crossing Set, Performer Hausdorf-Lock Guiding Sheath
Advice regarding a device removal. HPRA Ref: V30861
Coris BioConcept
RESIST-3 O.K.N. K-set
Advice regarding the use of the device. HPRA Ref: V30850
Diagnostica Stago
DISPOSABLE STA®-CUVETTES (REF. 38669) FOR HAEMOSTASIS ANALYSERS
Advice regarding a device removal. HPRA Ref: V30624
Diamed
ID-Cells - FSN 1
ID-Cells - FSN 2
Advice regarding the review of patient results/patient recall/sample retesting is required. HPRA Ref: V30834
DJO Surgical
RSP Monoblock & Turon Impaction Block Fixtures
Advice regarding a device removal. HPRA Ref: V30933
Draegerwerk AG & Co.
Oxylog 3000 and Oxylog 3000 plus
Advice regarding a software upgrade. HPRA Ref: V26479
Draegerwerk AG & Co.
Evita Infinity V500, Babylog VN500, Evita V300, with PS500 external battery
Advice regarding a software upgrade. HPRA Ref: V26796
EKF Diagnostic
Biosen Glucose / Lactate Consumables
Advice regarding a device removal. HPRA Ref: V30367
Fannin L.I.P.
Columbia Blood Agar+ Neomycin
Advice regarding a device removal. HPRA Ref: V30904
GE Healthcare
RFX/SFX, Legacy, Precision 500D
Advice regarding a device modification. HPRA Ref: V30900
Greatbatch
MobiCath™ Bi-Directional Guiding Sheath
Advice regarding a device removal. HPRA Ref: V30880
Hangzhou AGS MedTech Co. Ltd.
Hemoclip AG-51044-2300-090-16 - FSN 1
Hemoclip AG-51044-2300-090-16 - FSN 2
Advice regarding a device removal. HPRA Ref: V30794
Hitachi High-Technologies Cooperation
cobas® 8100 BRF and URF with Software Version 02-xx: Buffering May Cause Specimen Spillage
Advice regarding a software upgrade. HPRA Ref: V30958
LeMaitre Vascular
1.5mm Hydro LeMaitre® Valvulotome
Advice regarding a device removal. HPRA Ref: V28776
Maxter
ENTRAL ENFit™ nasogastric feeding tubes - Ranges NST, SFT, AND DFT.
Advice regarding changes/updates made to instructions for use. HPRa Ref: V30171
Medtronic
MiniMed 640G Insulin Pump
Advice regarding the use of the device. HPRA Ref: V30671
Merge Healthcare
Merge CADstream MRI PURE Filter
Advice regarding the use of the device. HPRA Ref: V28256
Merge Healthcare
Merge CADstream MRI Sureloc Application
Advice regarding the use of the device.HPRA Ref: V28257
METsis Medikal Teknik Sistemler Elektronik
Electrode pads manufactured by Medeks Medikal for Life-point Automatic External Defibrillators
Advice regarding a device removal. HPRA Ref: V29146
METsis Medikal Teknik Sistemler Elektronik
Life-point Automatic External Defibrillators
Advice regarding a software upgrade. HPRA Ref: V29146
Olympus
Olympus Diego Elite Tubeset
Advice regarding a device removal. HPRA Ref: V30844
Olympus Europa SE & Co. KG
Olympus URF-V2/URF-V2R Uretero-Reno Videoscopes & URF-P6/URF-P6R Ureteo-Reno Fiberscopes
Advice regarding a device removal. HPRA Ref: V30413
Phadia AB, ThermoFisher
ImmunoCAP Specific IgAIgG Sample Diluent
Advice regarding a device removal. HPRA Ref: V30690
Philips Healthcare
Efficia CMS200 Central Monitoring System
Advice regarding the use of the device. HPRA Ref: V30764
Physio-Control, Inc. USA
LIFEPAK 15 Difibrillator/Monitor
Advice regarding a device removal. HPRA Ref: V30840
Pinewood Healthcare
Emulsifying Ointment BP
Advice regarding a device removal. HPRA Ref: V30748
Randox
CRP Calibrator Series
Advice regarding changes/updates made to instructions for use. HPRA Ref: V30796
Randox Laboratories Limited
Liquid Cardiac Control - Myoglobulin
Advice regarding a device modification. HPRA Ref: V30960
Roche
cobas® 8000 modular analyzer series
Advice regarding changes/updates made to instructions for use. HPRA Ref: V30980
Schiller AG
AT-102 Plus Cardiovit
Advice regarding a software upgrade. HPRA Ref: V30761
Schiller Medical SAS
DEFIGARD Touch7 Defibfillator
Advice regarding a software upgrade. HPRA Ref: V30760
Shimadzu Corp.
Sonialvision Series G4/safire 17/ UD150B-40
Advice regarding a software upgrade. HPRA Ref: V30593
Siemens
ADVIA Centaur® Systems / Dimension Vista® Systems / IMMULITE® Systems
Advice regarding the use of the device. HPRA Ref: V30492
Siemens
ADVIA® Centaur XPT
Advice regarding the use of the device. HPRA Ref: V30772
Siemens AG
Artis Systems with Wireless Footswitch
Advice regarding the use of the device. HPRA Ref: V30956
Siemens Healthcare GmbH
MODULARIS Variostar
Advice regarding the use of the device. HPRA Ref: V30681
Siemens Healthcare GmbH
ARTISTE™, ONCOR™ and PRIMUS™
Advice regarding a software upgrade. HPRA Ref: V30890
Siemens Healthcare GmbH
Artis Q Systems with A100G Generators
Advice regarding a device modification. HPRA Ref: V30954
Siemens Healthineers
Artis Systems with software versions VC14, VC21, VD10, VD11 and VE10
Advice regarding changes/updates made to instructions for use. HPRA Ref: V30780
Topcon Medical Laser Systems Inc.
PASCAL Synthesis and PASCAL Synthesis TwinStar
Advice regarding the use of the device. HPRA Ref: V29170
Weinmann EMT
Battery pack for MEDUCORE Easy
Advice regarding a device removal. HPRA Ref: V30891
Zimmer Biomet
Various Polyethylene Implants
Advice regarding a device removal. HPRA Ref: V30972
Zimmer GmbH (Zimmer Biomet)
Metal heads (Modular Femoral Heads, Protasul® S30, Metasul® heads)
Advice regarding the use of the device. HPRA Ref: V30849
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Date Printed: 08/12/2023