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Summary of Field Safety Notices - December 2018
Notice type:
3rd Party Publications
Date:
03/01/2019
Further Information:
Abbott
Alinity i Processing Module
Advice regarding a device modification. HPRA Ref: V38363
Abbott Ireland Diagnostics Division
Architect B12 Reagent Kit
Advice regarding a device removal. HPRA Ref: V38285
Abbott Ireland Diagnostics Division
Architect Rubella IgM Reagent Kit
Advice regarding a device removal. HPRA Ref: V38287
ACUTRONIC Medical Systems AG
fabian +nCPAP evolution, fabian Therapy evolution
Advice regarding a device modification. HPRA Ref: V38082
ACUTRONIC Medical Systems AG
fabian HFO, fabian +nCPAP evolution, fabian Therapy evolution
Advice regarding a software upgrade. HPRA Ref: V38221
Allergan
Allergan Textured Breast Implants and Tissue Expanders
Advice regarding a device removal. HPRA Ref: V38348
Bayer Ltd.
Essure
Advice regarding the use of the device. HPRA Ref: V27207
Biohit Oyj
Lactose intolerance quick test. FSN 1
Lactose intolerance quick test. FSN 2
Advice regarding a device removal. HPRA Ref: V37995
Biomerieux
VITEK® 2 AST-N351 Test Kit
Advice regarding a device modification. HPRA Ref: V38299
CISBIO BIOASSAYS
CGA ELISA (overnight protocol), CGA-RIACT, PSA-RIACT, FPSA-RIACT, OCPG07-T4, OCPG57-T4, OCPE07-T3, OCPE57-T3 and ALDO-RIACT.
Advice regarding changes/updates made to instructions for use. HPRA Ref: V38134
ELITech B.V.
ELITech V-Twin Analyzer
Advice regarding the use of the device. HPRA Ref: V38276
Ethicon Endo Surgery , LLC
PROXIMATE® Hemorrhoidal Circular Stapler
Advice regarding a device removal. HPRA Ref: V38207
Flexicare
Laryseal Flexi Laryngeal Mask
Advice regarding the use of the device. HPRA Ref: V38286
GE Healthcare
Centricity Universal Viewer
Advice regarding a software upgrade. HPRA Ref: V38119
Integra Lifesciences
Mayfield Scull Clamps
Advice regarding changes/updates made to instructions for use. HPRA Ref: V38293
Medtronic Navigation
StealthAir™ Percutaneous Pin Adapter
Advice regarding a device removal. HPRA Ref: V38330
Natus Medical Inc
neoBLUE® blanket LED Phototherapy System
Advice regarding a device removal. HPRA Ref: V38215
Philips Medical Systems Nederland B.V
Intera, Omniva, Enterprise, Achieva, Achieva XR, Achieva Conversion, Panorama HFO, Ingenia, SmartPath to dStream, Multiva, Prodiva, MR-OR, MR-RT, MR-Linac, MR-Marlin systems
Advice regarding a device modification. HPRA Ref: V38371
Randox
Calcium
Advice regarding the use of the device. HPRA Ref: V38113
Randox
Fructosamine Calibrator (FRUC CAL), Fructosamine Control- Level 1 (FRUC CONTROL 1), Fructosamine Control- Level 3 (FRUC CONTROL 3).
Advice regarding the use of the device. HPRA Ref: V38153
Schulte-Elektromik GmbH
SISS BABYCONTROL
Advice regarding changes/updates made to instructions for use. HPRA Ref: V38298
Stryker Spine
Tritanium PL Spinal Cage
Advice regarding the use of the device. HPRA Ref: V38291
Terumo BCT
IV Pole Collar for Trima Accel® Automated Blood Collection System
Advice regarding a device modification. HPRA Ref: V38220
Terumo BCT
IV Pole Collar for Spectra Optia® Apheresis System
Advice regarding a device modification. HPRA Ref: V38219
Vertex-Dental B.V.
Vertex Implacryl
Advice regarding a device removal. HPRA Ref: V38217
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Date Printed: 04/10/2022