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Total Recall: Datascope/Getinge Gets Another Class I Recall For Its Aortic Balloon Pumps

 
• By Brian Bossetta

Datascope/Getinge has initiated yet another recall of its Intra-Aortic Balloon Pumps, this time because of a communication loss between the circuit board and video generator. The FDA has given this recall a class I designation.

electric heart Shutterstock_163911950
• Source: Shutterstock

Getinge subsidiary Datascope has launched yet another recall of its Intra-Aortic Balloon Pumps (IABPs), which are used to provide temporary support to the left ventricle during surgery. This comes only a few weeks after the most recent recall announcement but relates to a different problem.

The latest recall, initiated by the firm on 9 January, includes the Cardiosave Hybrid and Cardiosave Rescue models – the...

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• By Elizabeth Orr

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Finland Cracks Down On Software That Needs Regulating As A Medical Devices

 
• By Amanda Maxwell

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Finland Cracks Down On Software That Needs Regulating As A Medical Devices

 
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• By Vibha Sharma

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