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Home » Recall: Encision voluntarily pulls surgical tips | MassDevice.com On Call

Recall: Encision voluntarily pulls surgical tips | MassDevice.com On Call

October 17, 2011 By MassDevice staff

MassDevice On Call

MASSDEVICE ON CALL — Encision Inc. (PINK:ECIA) voluntarily recalled electrode tips used with its AEM surgical systems over concerns that the tips could break off as a result of "aggressive cleaning."

The Boulder, Colo.-based laparoscopic device maker said that a replacement instrument has been designed and is undergoing FDA review.

In the mean time, Encision is replacing existing tips with the prior model at no charge to customers, according to a press release.

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In connection with the recall, Encision announced that it recorded a one-time charge of $430,000 for the quarter ended September 30, 2011. That included non-cash charges of $105,000 for removal of affected tips already in inventory and for increasing warranty accruals.

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The Community Living Assistance Services & Support program, designed to provide benefits to people with disabilities who have paid into the program monthly for at least five years, became the subject of a probe by House Republicans who are concerned about how long it took for the Obama administration to slash it from health care laws, Healthwatch reported.

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The Apple iTunes app store boasts more than 60 apps for electronic health and medical records, EMR Daily News reported.

Filed Under: Electronic Medical Records (EMR), Healthcare Reform, News Well, Recalls Tagged With: Encision Inc.

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