Datascope
7 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Datascope and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-03-25FDA-DeviceClass IIICheck your Datascope battery charger left bay
The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging. The right bay of the Battery Charging Station is not affected by this issue.
- 2026-03-11FDA-DeviceClass IICheck your Datascope CS300 IABP battery info
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
- 2026-03-11FDA-DeviceClass IICheck your Datascope CS100 IABP instructions
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
- 2025-12-24FDA-DeviceClass IIICheck Cardiosave Rescue documentation for standards update
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
- 2025-12-24FDA-DeviceClass IIICheck your Cardiosave Hybrid documentation
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
- 2025-12-17FDA-DeviceClass IICheck Datascope Cardiosave Rescue maintenance schedule
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
- 2025-12-17FDA-DeviceClass IICheck Cardiosave Hybrid maintenance schedule update
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
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