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UPDATED - Urgent Product Defect Correction

Cardiosave Intra-Aortic Balloon Pumps (IABP) performance issues – Version 2

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JUNE2023 848208 Autofill Alarms_Gas Loss Gas Gain System Over Temp_Fiber Optic Damage

Datascope Corp., a subsidiary of Getinge is initiating a voluntary Medical Device Correction for the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) due to the…

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FEB2021 475699 Ripple 20

Datascope/Getinge is initiating a voluntary Medical Device Correction for the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) due to cybersecurity vulnerabilities…

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iabp-customer-workshops-perth-anz-102517-en.pdf

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JUNE2023 848201 11 Poor or No ECG Signal_Docking Power Battery Failure

Datascope Corp., a subsidiary of Getinge is initiating a voluntary Medical Device Correction for the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) due to the…

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Cardiosave Software Revisions

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Signature_Banner_Cardiosave_IABP_Training_Curriculum_OUS_MCA00003218_Rev A

Signature Banner Cardiosave IABP Training Curriculum for OUS

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Battery maintenance required

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Cardiosave Software Revisions

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TUV Certificate No. QS2 102541 0002 Rev. 04

TUV Certificate No.QS2 102541 0002 Rev. 04 / ISO 13485:2016 IABP and Accessories, HL40, Collagen Effective Date 2023-02-06 Exp. Date 2026-02-05

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