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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