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Document

Customer letter for four identified issues, July 31, 2023

Voluntary Medical Device Correction for the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) related to Autofill Alarms, Gas Loss & Gas Gain Alarms, System… Voluntary Medical Device Correction for the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) related to Autofill Alarms, Gas Loss & Gas Gain Alarms, System…

Document

JAN2023 783344 Safety Disks

This is a new recall, separate from the earlier reported recall involving four (4) issues regarding unexpected shutdown and helium leaks. Datascope Corp., a subsidiary of Getinge is… This is a new recall, separate from the earlier reported recall involving four (4) issues regarding unexpected shutdown and helium leaks. Datascope Corp., a subsidiary of Getinge is…

Talis RemoteView with +ACG on mobile Product

Talis RemoteView with +ACG

Clinical management and surveillance system with configurable clinical decision support Talis RemoteView with +ACG is an advanced platform for high-acuity care, empowering clinicians to… Clinical management and surveillance system with configurable clinical decision support Talis RemoteView with +ACG is an advanced platform for high-acuity care, empowering clinicians to…

Document

MCA000000556 C_US_Addendum to: Cardiosave IABP Operating Instructions-Clinical Considerations IAB IFU Balloon Membrane Perforation

MCA000000556 C_US_ Addendum to: Cardiosave IABP Operating Instructions-Clinical Considerations IAB IFU Balloon Membrane Perforation MCA000000556 C_US_ Addendum to: Cardiosave IABP Operating Instructions-Clinical Considerations IAB IFU Balloon Membrane Perforation

Surgeons in blue scrubs and masks focus intently during a surgical procedure in an operating room. Solutions

Cardiovascular and Vascular Procedure

As a partner for cardiovascular and cardiothoracic procedures, we offer technology and knowledge to help improve the clinical experience before, during and after surgery. As a partner for cardiovascular and cardiothoracic procedures, we offer technology and knowledge to help improve the clinical experience before, during and after surgery.

Document

Signature_Banner_IABP_Product_Support_Page_MCA00003220 Rev A_OUS

Signature Banner IABP Product Support Page MCA00003220 Rev A for OUS use Signature Banner IABP Product Support Page MCA00003220 Rev A for OUS use

Document

MDSAP Certificate TUV SUD QS6 102541 0004 Rev. 03 IABP and Accessories

MDSAP Certificate TUV SUD QS6 102541 0004 Rev. 03 IABP and Accessories, HL40, Collagen ISO 13485:2016 Effective: 2023-02-06 Exp. 2026-02-05 MDSAP Certificate TUV SUD QS6 102541 0004 Rev. 03 IABP and Accessories, HL40, Collagen ISO 13485:2016 Effective: 2023-02-06 Exp. 2026-02-05

Document

UPDATED - Urgent Medical Device Product Correction

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

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Updated Guidance for Managing the Cardiosave IABP Customer Presentation
Document

CS300 IABP: Operation and insertion of balloon

Quick reference guide Quick reference guide

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