May cause grave injuries or death: USFDA classifies recall of Getinge heart devices as most serious
An estimated 4,502 devices were recalled by the Swedish medical equipment maker's unit, Datascope, in the country in January, according to the US Food and Drug Administration (FDA).;
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Bengaluru: The US health regulator on Friday classified the recall of Getinge AB's heart devices as its most serious type as their use may cause grave injuries or death due to risk of unexpected shutdowns.
The company said it has informed its customers about the issue and there was no material financial impact from the recall.
An estimated 4,502 devices were recalled by the Swedish medical equipment maker's unit, Datascope, in the country in January, according to the US Food and Drug Administration (FDA).
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