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Summary of Field Safety Notices - August 2021
Notice type:
3rd Party Publications
Date:
02/09/2021
Further Information:
Summary of Field Safety Notices - August 2021
Abbott Laboratories
Alinity ci-series System Control Module (SCM)
Advice regarding a software upgrade. HPRA Ref: V47084
Acutronic Medical Systems AG
Fabian HFO, fabian +nCPAP evolution, and fabian Therapy evolution - FSN2
Advice regarding a software upgrade. HPRA Ref: V47032
Fabian HFO, fabian +nCPAP evolution, and fabian Therapy evolution - IFUAddendum2
Advice regarding a software upgrade. HPRA Ref: V47032
Armstrong Medical Ltd
2105489-003 AMSORB® PLUS PREFILLED G-CAN® 1.0L
Advice regarding a device removal. HPRA Ref: V47147
BD
llinois Bone Marrow Aspiration/ Intraosseous Needle, 15G x 79mm
Advice regarding a device removal. HPRA Ref: V47203
Beckman Coulter Inc
Access hsTnI Reagent (High Sensitivity Troponin I) - FSN
Advice regarding changes/updates made to instructions for use. HPRA Ref: V47339
Access hsTnI Reagent (High Sensitivity Troponin I) - Response Form
Advice regarding changes/updates made to instructions for use. HPRA Ref: V47339
Becton Dickinson Switzerland Sàrl
BD SmartSite Needle Free Valve - FSN
Advice regarding the use of the device. HPRA Ref: V46881
BD SmartSite Needle Free Valve - FSN Appendix1
Advice regarding the use of the device. HPRA Ref: V46881
Biocompatibles UK Limited
TheraSphere Administration Sets
Advice regarding the use of the device. HPRA Ref: V47096
Caesarea Medical Electronics Limited
BodyGuard Infusion System
Advice regarding a device modification. HPRA Ref: V46982
Cordis Corporation
Super Torqe MB Angiographic Catheter
Advice regarding changes/updates made to instructions for use. HPRA Ref: V47051
Dräger Medical GmbH
Atlan A300/ XL, Atlan A350/ XL
Advice regarding a software upgrade. HPRA Ref: V47307
Drägerwerk AG & Co KGaA
Evita V300, Evita V500 and Babylog VN500 ventilators
Advice regarding a software upgrade. HPRA Ref: V47232
GE Healthcare
Centricity IW PACS with Universal Viewer, Centricity Universal Viewer, Centricity Universal Viewer 6.0
Advice regarding a software upgrade. HPRA Ref: V47317
GS Elektromedizinische Geräte G. Stemple GmbH
Corpuls3 SLIM, corpuls3 Touch SLIM
Advice regarding a device modification. HPRA Ref: V47133
Karl Storz SE & Co. KG
FIVE S 3.5x65 - Flexible Video Intubation Laryngoscope
Advice regarding a device removal. HPRA Ref: V47218
Liko AB
OctoStretch with Stretch Leveler, FlexoStretch™, Stretch Leveler, LikoStretch™ 1900, LikoStretch™ Mod 600 IC.
Advice regarding a device removal. HPRA Ref: V47178
Maquet Cardiopulmonary GmbH
Heater-Cooler Unit HCU 40 - FSN
Advice regarding a device modification. HPRA Ref: V47292
Heater-Cooler Unit HCU 40 - Customer Reply Form
Advice regarding a device modification. HPRA Ref: V47292
Medline International Germany GmbH
Medline Sterile Procedure Trays including DRENOFAST Draining systems
Advice regarding changes/updates made to instructions for use. HPRA Ref: V47180
Medtronic Inc
DLP Left Heart Vent
Advice regarding a device removal. HPRA Ref: V47324
Nihon Kohden OrangeMed
Nihon Kohden Ventilators NKV-550-U
Advice regarding a device modification. HPRA Ref: V47252
Nipro Corporation
SURDIAL™ X
Advice regarding a software upgrade. HPRA Ref: V47170
Philips Medical Systems
Infant/Child SMART Pads Cartridges
Advice regarding a device removal. HPRA Ref: V47285
Respironics, Inc
Trilogy Evo, Trilogy Evo O2, Trilogy EV300 - FSN2
Advice regarding a software upgrade. HPRA Ref: V47028
Siemens Healthcare
Syngo.via RT Image Suite
Advice regarding a software upgrade. HPRA Ref: V47179
Thermo Fisher Scientific
Remel RapID™ NF System
Advice regarding a device removal. HPRA Ref: V47196
W.L Gore & Associates
GORE Cardioform Septal Occluder
Advice regarding a device removal. HPRA Ref: V47346
Welch Allyn Ltd
Braun Thermoscan PRO 6000 Ear thermometer - FSN
Advice regarding the use of the device. HPRA Ref: V47019
Braun Thermoscan PRO 6000 Ear thermometer - Attachment
Advice regarding the use of the device. HPRA Ref: V47019
Welch Allyn, Inc.
ELI280, MLBUR280 and BUR280 Electrocardiographs
Advice regarding a software upgrade. HPRA Ref: V47214
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Date Printed: 26/04/2024