Summary of Field Safety Notices - July 2021

Notice type: 3rd Party Publications

Date: 04/08/2021

 

Further Information:
Summary of Field Safety Notices - July 2021

Abbott GmbH & Co. KG
Alinity s System
Advice regarding a software upgrade. HPRA Ref: V46964

Accora Limited
Configura Advance
Advice regarding a device modification. HPRA Ref: V46900

Acutronic Medical Systems AG 
fabian HFO, fabian +nCPAP evolution, fabian Therapy evolution - FSN
Advice regarding a software upgrade. HPRA Ref: V47032

fabian HFO, fabian +nCPAP evolution, fabian Therapy evolution - Addendum
Advice regarding a software upgrade. HPRA Ref: V47032

Apollo Endosurgery, Inc. 
BIB / Orbera / Orbera365 Liquid-filled Intragastric Balloons
Advice regarding changes/updates made to instructions for use. HPRA Ref: V43617

Bbraun
PROSET INFUSION SET W. INTRAPUR FILTERS
Advice regarding a device removal. HPRA Ref: V47027

Boston Scientific
EMBLEM™ S-ICD Subcutaneous Electrode (Model 3501) - FSN2
Advice regarding a device removal. HPRA Ref: V45338

EMBLEM™ S-ICD Subcutaneous Electrode (Model 3501) - FSN3
Advice regarding a device removal. HPRA Ref: V45338

Covidien llc
Covidien DAR™ airway products - FSN3
Advice regarding a device removal. HPRA Ref: V46428

Ethicon Endo Surgery
HARMONIC HD 1000i Shears
Advice regarding a device removal. HPRA Ref: V46979

GE Medical Systems/GE Healthcare
SIGNA Premier, Signa Pioneer, SIGNA Architect, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR, SIGNA Voyager, Optima MR450w 1.5T, SIGNA Artist, 
SIGNA Creator, SIGNA Explorer, SIGNA MR355, SIGNA MR360, SIGNA MR380, Discovery MR450 1.5T, 1.5T Signa HDxt (HD28)

Advice regarding a software upgrade. HPRA Ref: V46908

Maquet Cardiopulmonary GmbH
Tubing sets for cardiopulmonary bypass - FSN
Advice regarding a device removal. HPRA Ref: V47022

Tubing sets for cardiopulmonary bypass - Annex I
Advice regarding a device removal. HPRA Ref: V47022

Medtronic
Vectris SureScan MRI Lead Kit
Advice regarding a device removal. HPRA Ref: V46931

Pipeline Flex Embolization device and Pipeline Flex with Shield Technology
Advice regarding a device removal. HPRA Ref: V47018

NEX Medical Antiseptics SRL
NEX 01 DRY surgical brush/sponge
Advice regarding a device removal. HPRA Ref: V46960

Olympus
GASTROINTESTINAL VIDEOSCOPE & COLONOVIDEOSCOPE
Advice regarding a software upgrade. HPRA Ref: V46978

Philips
Philips-EPIQ Ultrasound system
Advice regarding the use of the device. HPRA Ref: V47083

Respironics California, LLC
Philips V60/V60 Plus Ventilators - FSN
Advice regarding the use of the device. HPRA Ref: V46955

Philips V60/V60 Plus Ventilators - Addendum
Advice regarding the use of the device. HPRA Ref: V46955

Respironics, Inc.
Trilogy Evo, Trilogy Evo O2, Trilogy EV300 - FSN for hospitals
Advice regarding the use of the device. HPRA Ref: V47028

Trilogy Evo, Trilogy Evo O2, Trilogy EV300 - FSN for Home Users
Advice regarding the use of the device. HPRA Ref: V47028

Roche
Elecsys CA 19-9 on cobas e 801 and e402 - FSN7
Advice regarding the use of the device. HPRA Ref: V42751

Roche Diagnostics GmbH
Accu-Chek®Aviva, Performa and Inform II test strip - FSN1
Advice regarding the use of the device. HPRA Ref: V46991

Accu-Chek®Aviva, Performa and Inform II test strip - FSN2
Advice regarding the use of the device. HPRA Ref: V46991

Accu-Chek®Aviva, Performa and Inform II test strip - FSN3
Advice regarding the use of the device. HPRA Ref: V46991

Roche Diagnostics Manheim
Iron 2 - FSN2
Advice regarding the use of the device. HPRA Ref: V46371

Siemens Healthcare
Artis zee / Q / Q.zen
Advice regarding a software upgrade. HPRA Ref: V46906

Sony
SONY LCD Monitor LMD-X270x Series
Advice regarding a device modification. HPRA Ref: V46850

Tornier
AEQUALIS™ PYROCARBON Humeral Head Implant
Advice regarding the use of the device. HPRA Ref: V46832

W.L Gore & Associates
GORE Molding and Occlusion Balloon Catheters
Advice regarding a device removal. HPRA Ref: V46945


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