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However, the agency said the company failed to correct defects in its HeartStart AEDs, which led to deaths, according to the FDA letter. The agency sent a warning letter in late March to Philips about its automated external defibrillators (AEDs). The FDA also warned Royal Philips Electronics NV (NYSE: PHG) on automated external defibrillator defects.

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28 and reports that no adverse events related to the software glitch occurred. The company notified its customers of the defect on Feb. The recall includes MoogвЂ™s Curlin 6000 CMS, Curlin 6000 CMS IOD, PainSmart and PainSmart IOD devices manufactured and given software updates from May 2007 to February 2011, according to the company. The FDA also issued a class I recall for MoogвЂ™s infusion pumps after it found that a software error in the pumps can cause them to shut down prematurely and cause patient death or serious injury, according to the FDA. Penumbra began contacting its customers about the defect on March 4 and said that it can account for all affected lots. The recall affects lot numbers F17211 to F18553. According to the FDA, the pull wire on the delivery tool can slip out of place and allow premature detachment of the coil, which may cause the coil to slip into the blood stream and lead to serious injury including blood clots and stroke. The deviceвЂ™s implantation system includes a tool used to insert it inside a patient.

The Penumbra device is a platinum coil designed that is placed into a brain aneurysm through the blood vessels. In other recall news, the agency also issued a Class 1 recall of an aneurysm treatment device made by Penumbra Inc. iCad sent a letter to its customers about the defect on Feb. Only 'a few' effects have been reported in humans with Tungsten and each of which involved exposure to much higher levels, the agency said. The agency said that there isnвЂ™t evidence that the tungsten particles are toxic, and no 'permanent impairment of bodily functions or permanent damage to body structures is anticipated,' according to the FDA.

ICad bought out Axxent maker Xoft late last year for about $13.1 million in stock and cash. iCad was sued last month over the tungsten deposits found in patientsвЂ™ breast tissue after treatment with the devices in a California Hospital. The recall came on reports that tungsten particles from the shielding devices became lodged in the breast tissue of women who were treated with the device during intraoperative radiation therapy (IORT). The Food & Drug Administration issues Class I recalls when there is potential for serious injury or death from use of a particular device or product. The FDA issued the Class I recall for Sunnyvale, Calif.-based companyвЂ™s Axxent FlexiShield Mini, Model F5300. (NSDQ: ICAD), formerly Xoft Inc., had to remove a radiation guard for breast cancer treatment, over reports that the device sheds tungsten particles. Earlier this year, the Senate passed the historic, bipartisan United States Innovation and Competition Act, which also included key priorities secured by Senator Hassan to help boost the economy and harden critical infrastructure.The FDA released a flurry of recalls for medical devices this week.ДЇirst, iCad Inc. Senator Hassan is working to support innovative businesses in New Hampshire and across the country.В As Governor of New Hampshire, Senator Hassan doubled the supply of state R&D tax credits and made the credit permanent. Their work is helping to transform our fight against cancer and I will continue supporting cancer research in Congress.вЂќ вЂњI was glad to have the opportunity to visit iCAD in Nashua, which is doing innovative work to improve breast cancer detection and treatment. вЂњAs we markВ Breast Cancer Awareness Month, itвЂ™s important for all of us to recognize how many lives cancer has touched and encourage our loved ones to get screened for not only breast cancer, but other diseases as well,вЂќ Senator Hassan said. The company uses Artificial Intelligence technology to help health care providers more quickly and accurately detect breast cancer in patients. Senator Maggie Hassan (D-NH) toured iCAD, an innovative business in Nashua that provides cancer detection and therapy solutions for a variety of different cancers, including breast cancer. NASHUA вЂ“ In recognition of Breast Cancer Awareness Month, U.S. Senator Hassan Visits with iCAD Employees. OctoSenator Hassan Tours Cancer Detection and Treatment Company iCAD in Nashua During Breast Cancer Awareness Month

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