Categories
rss

Continuous Ventilator Correction: Baxter Healthcare Corporation Issues Correction for Life2000 Ventilator due to a nonconforming battery charger, which triggers a battery alarm and renders the ventilator inoperable

Murilo Freitas - 05:00, 4 de February de 2025120
Baxter Healthcare is recalling the Life2000 Ventilator System by correction, due to a defective battery charger making the ventilator inoperable.

http://www.fda.gov/medical-devices/medical-device-recalls/continuous-ventilator-correction-baxter-healthcare-corporation-issues-correction-life2000-ventilator

 
Categories
rss

FDA Alerts Patients to Regularly Check Diabetes-Related Smartphone Device Alert Settings, Especially Following Phone Hardware or Software Changes

Murilo Freitas - 05:00, 4 de February de 2025124
The FDA is alerting users of diabetes-related medical devices that smartphones connected to diabetes devices may fail to send critical safety alerts.

http://www.fda.gov/medical-devices/safety-communications/fda-alerts-patients-regularly-check-diabetes-related-smartphone-device-alert-settings-especially

 
Categories
rss

Oxygen Concentrator Recall: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD Removes JMC5A Ni/TruAire-5 Oxygen Concentrator due to the devices spontaneously catching fire

Murilo Freitas - 05:00, 4 de February de 2025155
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD is recalling certain devices due to incidents of device melting and fire during the use of oxygen concentrators.

http://www.fda.gov/medical-devices/medical-device-recalls/oxygen-concentrator-recall-jiangsu-jumao-x-care-medical-equipment-co-ltd-removes-jmc5a-nitruaire-5

 
Categories
rss

Pressure Monitoring Device Recall: Medtronic Neurosurgery Issues Correction for Becker and Exacta External Drainage and Monitoring Systems Due to Cracks And/Or Leaks in Stopcocks

Murilo Freitas - 05:00, 2 de February de 2025190
Becker and Exacta EDMS are used for draining and monitoring cerebrospinal fluid in the brain. Stopcocks may have cracks or leaks that pose a risk to patients.

http://www.fda.gov/medical-devices/medical-device-recalls/pressure-monitoring-device-recall-medtronic-neurosurgery-issues-correction-becker-and-exacta

 
Categories
rss

Gas Powered Emergency Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece Resuscitator Due to An Undersized Spring in The Controller That May Prevent the Device from Delivering the Required Pressure Levels Needed for Effective Ventilation

Murilo Freitas - 05:00, 30 de January de 202598
Mercury Medical recalls the Neo-Tee T-Piece Resuscitator due to the controller potentially not delivering the pressure levels needed for effective ventilation.

http://www.fda.gov/medical-devices/medical-device-recalls/gas-powered-emergency-resuscitator-recall-mercury-medical-removes-neo-tee-t-piece-resuscitator-due

 
Categories
rss

Alvogen Issues Voluntary Nationwide Recall for One Lot of Fentanyl Transdermal System 25 mcg/h Due to a Defective Delivery System

Murilo Freitas - 05:00, 30 de January de 202591
Alvogen, Inc. is voluntarily recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches to the consumer level. The reason for the recall is that there is a potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch. This transdermal s

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/alvogen-issues-voluntary-nationwide-recall-one-lot-fentanyl-transdermal-system-25-mcgh-due-defective

 
PRAIS 2.0