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Class I Medical Device Recall: Zimmer Biomet Recalls Comprehensive Reverse Shoulder due to a High Fracture Rate
<!– –> <!– Page Last Updated: 02/15/2017 –> Page Last Updated: 02/15/2017 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français |…
Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150038 and DEN150057 added)
<!– –> <!– Page Last Updated: 02/13/2017 –> Page Last Updated: 02/13/2017 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français |…
Class I Medical Device Recall: Physio-Control Recalls LIFEPAK15 Monitor/Defibrillator Due to Failure of Electrical Shock Delivery
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product The LIFEPAK 15 Monitor/Defibrillator (LP15) Serial Numbers: See full list below Distribution Dates: September 13, 2014, to July 4, 2016 Manufacturing Dates: September 3, 2014 to June…
The FDA alerts health care providers about potential risks with fluid-filled intragastric balloons
February 9, 2017 Dear Health Care Provider, The FDA has recently received multiple reports for two different types of adverse events associated with fluid-filled intragastric balloons used to treat obesity. We recommend that you closely monitor patients with these devices for these adverse events, and to submit reports to help us better understand any complications…
Federal Register: Physio-Control Recalls LIFEPAK15 Monitor/Defibrillator Due to Failure of Electrical Shock Delivery
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product The LIFEPAK 15 Monitor/Defibrillator (LP15) Serial Numbers: See full list below Distribution Dates: September 13, 2014, to July 4, 2016 Manufacturing Dates: September 3, 2014 to June…
Physio-Control Recalls LIFEPAK15 Monitor/Defibrillator Due to Failure of Electrical Shock Delivery
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product The LIFEPAK 15 Monitor/Defibrillator (LP15) Serial Numbers: See full list below Distribution Dates: September 13, 2014, to July 4, 2016 Manufacturing Dates: September 3, 2014 to June…
Class I Medical Device Recall: CareFusion Recalls Alaris Syringe Pump due to an Alarm Error Which May Cause Interruption of Therapy
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Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150035 and DEN140017 added)
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January 2017 PMA Approvals
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