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Summary of Field Safety Notices - July 2018
Notice type:
3rd Party Publications
Date:
02/08/2018
Further Information:
Abbott
ARCHITECT Creatine Kinase
Advice regarding a device removal. HPRA Ref: V36560
Abbott
Alinity s System
Advice regarding the use of the device. HPRA Ref: V36579
Abbott
ARCHITECT EBV VCA IgM Reagent Kit
Advice regarding the use of the device. HPRA Ref: V36604
B.Braun
Perifix Catheter Connector
Advice regarding the use of the device. HPRA Ref: V36421
BioMerieux Inc.
BacT/ALERT® VIRTUO™ Microbial Detection System
Advice regarding a device modification. HPRA Ref: V36354
Cantel Medical Limited
SureStore
Advice regarding changes/updates made to instructions for use: HPRA Ref: V36238
Cepheid
Xpert® C.Difficile BT assay
Advice regarding a device removal. HPRA Ref: V36575
ConvaTec Limited
Suction Catheters, Gastro-enteral Tubes
Advice regarding a device removal. HPRa Ref: V36438
Cook Medical Europe
Chorion Villus Biopsy Needle Set
Advice regarding a device removal. HPRA Ref: V36371
Covidien llc
BIS™ Vista and BIS™ View Monitoring Systems
Advice regarding a device modification. HPRA Ref: V36610
DiaSys Deutschland Vertriebs-GmbH
CK-MB FS and GLDH FS DGKC
Advice regarding the use of the device. HPRA Ref: V36366
DXC Technology
ILAB AKI 2.1 Build 5
Advice regarding the use of the device. HPRA Ref: v36384
Fannin Ltd.
Brilliance UTI Clarity Agar
Advice regarding a device removal. HPRA Ref: V36586
FREI AG
ARCUS Treatment Tables
Advice regarding a device modification. HPRA Ref: V36227
GE Healthcare
CARESCAPE Monitor B650
Advice regarding the use of the device. HPRA Ref: V36303
GE Medical Systems LLC
Discovery MR750w
Advice regarding a device modification. HPRA Ref: V36177
Getinge (Maquet Cardiopulmonary GmbH)
HCU 40
Advice regarding a device modification. HPRA Ref: V36647
Immucor
Panocell®-10 FSN 1
Panocell®-10 FSN 2
Panocell®-10 FSN 3
Panocell®-10 FSN 4
Advice regarding the use of the device. HPRA Ref: V36629
Intuitive Surgical, Inc
Surgical staple, non-bioabsorbable
Advice regarding a device removal. HPRA Ref: V35652
Intuitive Surgical, Inc
da Vinci Xi EndoWrist Suction Irrigator
Advice regarding the use of the device. HPRA Ref: V36132
Isoman Teoranta
Thermablate EAS
Advice regarding changes/updates made to instructions for use. HPRA Ref: V36480
Linkage Biosciences, Inc.
LinkSēq HLA ABCDRDQDP SABR 384 Typing Kit (1580C), LinkSeq HLA ABCDRDQDP+ 384 (1575C)
Advice regarding the use of the device. HPRA Ref: V36637
Livanova Canada Corp
Perceval Sutureless Heart Valve
Advice regarding changes/updates made to instructions for use. HPRA Ref: V36089
Luminex Corporation
ARIES® System, ARIES® M1 System barcode scanner
Advice regarding a device modification. HPRA Ref: V36448
Mast Group
Ciprofloxacin 0.5mg/L Plate
Advice regarding a device removal. HPRA Ref: V36541
Medtronic
Guardian™ Connect Application FSN 1
Guardian™ Connect Application FSN 2
Guardian™ Connect Application FSN 3
Advice regarding a software upgrade. HPRA Ref: V36364
Medtronic
Single Chamber Temporary Pacemaker
Advice regarding a software upgrade. HPRA Ref: V36103
Medtronic Inc.
Vectris™ Lead Kits
Advice regarding a device removal. HPRA Ref:V36504
MicroPort CRM (formerly LivaNova)
PLANTINIUM ICDs and CRT-Ds
Advice regarding a device removal. HPRA Ref: V36478
MPS Medical Product Service GmbH
Aluminum Dewars
Advice regarding a device removal. HPRA Ref: V35744
NeoTract
UroLift® System UL400
Advice regarding a device removal. HPRA Ref: V36529
Philips Healthcare
SureSigns VS & VM Monitors, and View Station (VSV)
Advice regarding the use of the device. HPRA Ref: V36434
Philips Medical Systems DMC GmbH
Patient Support
Advice regarding a device modification. HPRA Ref: V36122
Philips Medical Systems Nederland BV
Allura Xper, INTEGRIS systems (Poly C-OMCP- Visub / Cesar-OMCP-Visub)
Advice regarding a device modification. HPRA Ref: V36540
Randox
Liquid Assayed Specific Protein Controls
Liquid Assayed Specific Protein Controls IFU 1
Liquid Assayed Specific Protein Controls IFU 2
Liquid Assayed Specific Protein Controls IFU 3
Advice regarding changes/updates made to instructions for use. HPRA Ref: V35778
Reckitt Benckiser Healthcare (UK) Limited
Durex Real Feel ‘Latex‐free’ and Durex Latex Free Polyisoprene condoms
Advice regarding a device removal. HPRA Ref: V36620
Regenlab
Cellular Matrix BCT-HA-1 and 3T, Cellular Matrix A-CP-HA-1 and 3T, ArthroVisc40-1, SkinVisc40-1.
Advice regarding a device removal. HPRA Ref: V36621
Siemens
ADVIA Centaur XPT System
Advice regarding a software upgrade. HPRA Ref: V30772
Siemens Healthcare Diagnostics, Inc.
RAPIDPoint® 405/500 Systems, RAPIDLab® 1245/1265 Systems
Advice regarding the use of the device. HPRA Ref: V36569
Siemens Healthineers
ARTIS Q and ARTIS pheno
Advice regarding a software upgrade. HPRA Ref: V36627
Smith & Nephew
JELONET 15CM X 2M CTN 12 _ 7415
Advice regarding a device removal. HPRA Ref: V36537
Stago
STA Néoplastine® CI Plus, STA Néoplastine® CI
Advice regarding the use of the device. HPRA Ref: V36557
STERIS
STERIS V-PRO 1, V-PRO 1 Plus, V-PRO maX Low Temperature Sterilization Systems
Advice regarding a software upgrade. HPRA Ref: V36566
Thermo Fisher Scientific
Thermo Scientific™ Remel™ Agglutinating Sera Shigella boydii Polyvalent 2 (7 to 11)
Advice regarding the use of the device. HPRA Ref: V36353
Weinmann
MEDUMAT Transport
Advice regarding a software upgrade. HPRA Ref: V36305
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Date Printed: 25/04/2024