Suchergebnis für "IABP"

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…

Addendum to: Cardiosave IABP Operating Instructions - Clinical Considerations IAB IFU Balloon Membrane Perforation MCA000000549 C_OUS

Addendum to: Cardiosave IABP Operating Instructions - Clinical Considerations IAB IFU Balloon Membrane Perforation MCA000000549 C_OUS

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…

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

Signature_Banner_IABP_Product_Support_Page_MCA00003220 Rev A_OUS

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

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

UPDATED - Urgent Medical Device Product Correction

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

Updated Guidance for Managing the Cardiosave IABP Customer Presentation

CS300 IABP: Operation and insertion of balloon

Quick reference guide

UPDATED - Urgent Product Defect Correction

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