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Summary of Field Safety Notices - June 2018
Notice type:
3rd Party Publications
Date:
02/07/2018
Further Information:
Abbott
CardioMEMS™ Patient Electronics System
Advice regarding a device removal. HPRA Ref: V36116
AGFA
Enterprise Imaging for Radiology
Advice regarding the use of the device. HPRA Ref: V36193
Angio Dynamics Inc.
Procedures Kit
Advice regarding a device removal. HPRA Ref: V36105
Armstrong Medical
CPAP Breathing Systems for Adults
Advice regarding changes/updates made to instructions for use. HPRA Ref: V35784
Baxter
Prismaflex 7.XX Row, Prismaflex 8.XX Row
Advice regarding a software upgrade. HPRA Ref: V35826
BD Switzerland Sàrl
Alaris™/ Asena™ GS, GH, CC, TIVA, PK, Enteral Syringe Pump
Advice regarding a device modification. HPRA Ref: V36189
Becton Dickinson and Company
BD Vacutainer™ Urine Collection Cup
Advice regarding a device removal. HPRA Ref: V36052
BioFire Diagnostics, LLC
FilmArray® Blood Culture Identification (BCID) Panel
Advice regarding the use of the device. HPRA Ref: V35292
Bio-Rad
MRSASelect™II
Advice regarding the use of the device. HPRA Ref: V36082
Boston Scientific
INGEVITY MRI
Advice regarding changes/updates made to instructions for use. HPRA Ref: V33404
Boston Scientific
Maestro 4000 Cardiac Ablation System
Advice regarding a device modification. HPRA Ref: V36123
Bovie
J-Plasma Precise® 360 Handpiece
Advice regarding a device removal. HPRA Ref: V36221
Coltene
UNITY Drills for stainless steel, Pin 3 pieces, UNITY Complete-Kit, UNITY Bluk Kit
Advice regarding a device removal. HPRA Ref: V36083
Dentsply Sirona
CEREC AC / AF / AI with Omnicam
Advice regarding the use of the device. HPRA Ref: V36093
Frei AG
ARCUS treatment tables
Advice regarding the use of the device. HPRA Ref: V36227
GE Medical Systems LLC
MRI systems Software Version issue
Advice regarding a software upgrade. HPRA Ref: V36235
Heinrich Medika
Sterile and Non-Sterile Electrosurgical Products
Advice regarding a device removal. HPRA Ref: V36124
Integra Life Sciences
TITAN™ Total Modular Shoulder System (TSS) Humeral Stem Trials
Advice regarding a device removal. HPRA Ref: V34364
Intuitive Surgical
da Vinci® Si™ / Xi™ / X™ Surgical System
Advice regarding a device modification. HPRA Ref: V36283
LivaNova Canada Corp.
Perceval Sutureless Heart Valve
Advice regarding the use of the device. HPRA Ref: V36089
Mast Group Ltd.
AUGMENTIN 32mg/L PLATE, MPM-AUG32
Advice regarding the use of the device. HPRA Ref: V36073
Medline International Germany GmbH
Hydroline® Trumpet Valves
Advice regarding a device removal. HPRA Ref: V36206
Medtronic Inc.
MICROPLAS plasmafilters
Advice regarding the use of the device. HPRA Ref: V35422
Medtronic Inc.
Single Chamber Temporary Pacemaker
Advice regarding a software upgrade. HPRA Ref: V36103
Medtronic Inc.
Percepta™ CRT-P MRI SureScan™ and Percepta™ Quad CRT-P MRI SureScan™
Advice regarding a software upgrade. HPRA Ref: V36241
Medtronic Inc.
EnTrust® and Escudo® VR/DR/AT ICDs
Advice regarding the use of the device. HPRA Ref: V36245
Philips Medical Systems
Allura Xper, UNIQ, Centron
Advice regarding a software upgrade. HPRA Ref: V36120
Prism Medical
Freeway Easyfit System
Advice regarding a device modification. HPRA Ref: V32394
Radiometer
ABL800
Advice regarding a software upgrade. HPRA Ref: V36192
Randox
Liquid Assayed Specific Protein Controls
Advice regarding changes/updates made to instructions for use. HPRA Ref: V35778
Randox
Randox Liquid Cardiac Control. FSN
Randox Liquid Cardiac Control. IFU
Advice regarding changes/updates made to instructions for use. HPRA Ref: V36096
Roche Diagnostics GmBH
MagNA Pure 24 System
Advice regarding the use of the device. HPRA Ref: V35702
Roche Roche Diagnostics GmbH
Cobas p612 pre-analytical system (LCP1)
Advice regarding the use of the device. HPRA Ref: V36296
Schiller Medical
DEFIGARD Touch 7
Advice regarding a software upgrade. HPRA Ref: V36180
Siemens AG
Artis Q/pheno systems
Advice regarding a device modification. HPRA Ref: V36228
Siemens Heathcare GmbH
Artis zee/Q/Q.Zen
Advice regarding a software upgrade. HPRA Ref: V35872
Stryker
LFIT Anatomic CoCr V40 Femoral Heads
Advice regarding the use of the device. HPRA Ref: V36019
Stryker
T2 Ankle Arthrodesis Nails / Proximal Humeral Nails
Advice regarding a device removal. HPRA Ref: V36182
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Date Printed: 25/04/2024