FDA (Devices) recall action 97956
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
The agency’s own wording, quoted from the enforcement report.
Datascope is recalling 11,470 Cardiosave Hybrid units to issue an instructions for use addendum updating the Vibration and Shock Table to reference the correct standards.
Datascope is recalling 47 Cardiosave Rescue units to issue an instructions for use addendum updating the Vibration and Shock Table to reference the correct standards.