• Heartsine Technologies (Newtown, Pennsylvania) received Class I recall status from the FDA for its Samaritan defibrillators. According to a warning issued by the FDA, the defibrillators may have a battery defect that could lead to serious injury or death. According to the FDA report, Samaritan 300 and Samaritan 300P defibrillators may turn on and off without warning. Since these public access defibrillators must be available on-demand to save lives, this issue can impact patient safety and wellbeing. In some cases, the defibrillator may not be able to deliver corrective therapy to a patient experiencing cardiac arrest. As of now, there have been no deaths conclusively linked with the battery issues in Heartsine Samaritan defibrillators. However, there have been five deaths reported to the FDA that may be linked with the use of the defibrillator system.

• Raiing (Biejing) has been granted FDA clearance for the Raiing Wireless Thermometer, a peel-and-stick contact thermometer sensor that continuously transmits body temperature readings to a companion iPhone app, which is already available in the iOS AppStore. The app is called Vitals Monitor and is currently available for a free download. The device, which is worn under the armpit, uses Bluetooth to transmit data in real time to the iPhone, according to Raiing's website. The thermometer can also store up to 72 hours worth of readings According to the FDA filing, the device is battery-operated, reusable, and intended for use by ages two and up. Raiing says its contact thermometer appears to be the first smartphone-enabled body temperature thermometer to secure FDA clearance.

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