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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