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Summary of Field Safety Notices - May 2023
Notice type:
3rd Party Publications
Date:
02/06/2023
Further Information:
May Olympus Medical Systems Corporation
SINGLE USE REPOSITIONABLE CLIP HX-202LR/UR
Advice regarding a device removal, HPRA Ref: V54985
Abbott Ireland Diagnostics Division
Alinity I Anti-TPO Reagent Kit
Advice regarding the use of the device, HPRA Ref: V54841
Carnamedica Sp. z o.o.
Belzer UW® ; Belzer MPS®; StoreProtect®
Advice regarding a device removal, HPRA Ref: V54019
Cook Medical
Hemospray Endoscopic Hemostat
Advice regarding the use of the device, HPRA Ref: V55165
Davol Inc., Subsidiary of C. R. Bard
Ventralight™ ST Mesh with Echo PS™ Positioning Sy
s
Advice regarding a device removal, HPRA Ref: V55033
Drägerwerk AG & Co. KGaA
Oxylog 3000 plus
Advice regarding the use of the device, HPRA Ref:V55173
Edwards Lifesciences LLC
Fore-Sight Elite Tissue Oximeter Module
Advice regarding a software upgrade, HPRA Ref:V50572
F Care Systems NV
Fistura catheter
Advice regarding changes/updates made to instructions for use, HPRA Ref:V55153
Fannin Ltd
Fastidious Anaerobic Agar + Horse Blood.
Advice regarding the use of the device, HPRA Ref:V55085
Gyrus ACMI, Inc. (Olympus Surgical Technologies America)
UroPass® Ureteral Access Sheath Set
Advice regarding a device removal, HPRA Ref:V55101
Hammatsu Photonics
NanoZoomer Series
Advice regarding the use of the device, HPRA Ref:V55050
HeartSine Technologies
HeartSine samaritan® PAD
Advice regarding a device removal, HPRA Ref:V55184
Illumina
NextSeq™ 550Dx and MiSeq™Dx instruments
Advice regarding a software upgrade, HPRA Ref:V55057
Intersurgical Ltd
Superset Fixed Elbow Catheter Mount 22F-22M/15F
Advice regarding a device removal, HPRA Ref:V55288
Löwenstein Medical Technology GmbH + Co. KG
LUISA ventilator (LM150TD)
Advice regarding a software upgrade, HPRA Ref:V55091
Max Mobility LLC
Smartdrive MX2+with Pushtracker E2/E3
Advice regarding a software upgrade, HPRA Ref:V55118
Medline International France SAS/Turkuaz Sağlık
Sterile Ultrasound Gel
Advice regarding a device removal, HPRA Ref:V55169
Medtronic Inc.
Cobalt™ XT/Cobalt™/Crome™ ICDs and CRT-Ds, Claria MRI™/Amplia MRI™/Compia MRI™/Viva™/Brava™ CRT-Ds, Visia AF™/Visia AF MRI™/Evera™/Evera MRI™/Primo MRI™/Mirro MRI™ ICDs
Advice regarding the use of the device, HPRA Ref:V55139
NOxBOX Ltd.
NOxBOXi Nitric Oxide Delivery Device (NOXBOX-I)
Advice regarding the use of the device, HPRA Ref:V55092
NRT
Intelli-C
Advice regarding a device modification, HPRA Ref: V55218
Phadia AB
EliA GBM Well Test
Advice regarding the use of the device, HPRA Ref:V55166
Philips
Patient Information Center iX and IntelliVue MX40
Advice regarding a software upgrade, HPRA Ref:V55240
Philips Respironics
Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, Trilogy EV300
Advice regarding a device modification, HPRA Ref: V54744
RAL Diagnostics
Buffer solution for automated systmes
Advice regarding a device removal, HPRA Ref:V54972
Randox
Immunoassay Premium Level 3 and Immunoassay Premium Control Tri Level
Advice regarding a device modification, HPRA Ref: V55022
Schiller AG
Tempus LS
Advice regarding a device modification, HPRA Ref:V54762
Smiths Medical
Jelco® Optiva® IV Catheter 5063-AI
Advice regarding a device removal, HPRA Ref: V54756
Stryker Joint Replacement
Exeter V40 Trial Head
Advice regarding a device removal, HPRA Ref: V55167
Sylk Ltd
SYLK Intimate
Advice regarding a device removal, HPRA Ref: V55205
Teleflex Medical
Weck® Horizon™, HORIZON TI MICRO 6/CART 180/BOX
Advice regarding a device removal, HPRA Ref: V55038
Teleflex Medical
Endotracheal Tubes - See FSN for full list
Advice regarding a device removal, HPRA Ref: V55186
UFSK-International OSYS
UFSK-OSYS 500 XL
Advice regarding the use of the device, HPRA Ref: V55117
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Date Printed: 25/04/2024