January 2016 MedSun Newsletter
Recalls and Safety Alerts:
Chariot Guiding Sheath by Boston Scientific: Recall
The recall was initiated on November 19, 2015 due to the risk of shaft separation. These events occurred during device preparation or use…
Inspiration LS, 5i and 7i Ventilator Systems by eVent Medical: Class I Recall
A faulty switch on the ventilators’ power board may fail, causing the ventilator to shut down without sounding an alarm...
OmniPod Insulin Management System by Insulet: Field Safety Notification
This Notification is due to a slight increase in the reported cases in which the Pod’s needle mechanism failed to deploy or there was a delay in the deployment of the needle mechanism. In the event a needle mechanism fails to deploy, the needle will not be inserted and insulin delivery will not begin…
Digital Temple Thermometer (DTT) by K-Jump Health Co., Ltd.: Recall
Some devices contain a manufacturing problem causing the affected thermometers to display temperatures that are inaccurate and lower than actual body temperatures, which potentially may cause the user or caregiver of the user to delay or forego seeking appropriate care or receive more care than appropriate…
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