Philips is scrutinizing a recall of its ventilators and respiratory devices from the U.S. FDA as the company attempts to correct course since its shares dipped significantly following the recall in April.
Dutch medical equipment maker Philips said U.S. regulators might have overestimated the number of safety issues raised by customers related to its recall of ventilators in which a potentially hazardous foam was used.
The FDA this month said Philips’ evaluation of health risks was inadequate, as it had found tens of thousands more complaints in the company’s customer database than the almost 1,250 reported by Philips.
“The complaints that were referenced by the FDA are the result of a very broad search. Therefore the complaints did not necessarily relate specifically to the issue that led to the recall,” Philips CEO Frans van Houten told reporters.
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