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December 12, 2012
14:59 EDTBABYNatus Medical says FDA re-classified recall as Class I, expected cost immaterial
Natus Medical Incorporated released a statement regarding the issuance by the FDA of a recall notice for the company's Olympic Cool-Cap. The recall addresses a situation where the Cool-Cap screen freezes and interrupts patient cooling. Natus had previously communicated the problem to customers in May by issuing a Class II recall notice, which is the FDA's mid-level health hazard classification. Customers are able to recover from the screen freeze failure by simply rebooting the Cool-Cap system. Cooling treatment can continue in a safe manner with the Cool-Cap system as originally intended. The company has provided recall information to the FDA as required in a timely manner since this problem originated. Today's announcement indicates that the FDA has re-classified this action as a Class I recall which is the highest relative degree of health hazard classification for a product recall. As a result of this reclassification, Natus will be sending follow up safety notice letters to all customers reminding them how to recognize this screen freeze condition and how to recover from it. Separately, an unreliable power supply module is being replaced on an ongoing basis in effected units. The costs of the measures described above are not expected to be material, including costs yet to be incurred, and were previously accrued as an expense in the company's financial results for the nine months ended September 30. The recall does not prevent the company from continuing to market and sell the Cool-Cap, nor does it prevent clinicians from using the device. Revenue from the Cool-Cap represents less than 1% of the company's consolidated revenue.
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April 23, 2014
07:34 EDTBABYNatus Medical raises FY14 EPS view to $1.18-$1.21 from $1.14-$1.18
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07:33 EDTBABYNatus Medical sees Q2 EPS 24c-27c, consensus 26c
Sees Q2 revenue $83M-$86M, consensus $84.8M.
07:33 EDTBABYNatus Medical reports Q1 EPS 26c, consensus 23c
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