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Max Mobility / Permobil Issues Nationwide Recall of SmartDrive Speed Control Dial Due to the Motor Being Unresponsive to the User

Murilo Freitas - 20:00, 16 de January de 2025218
Max Mobility/Permobil has initiated a nationwide recall of the Speed Control Dial component used with the SmartDrive MX2+ Power Assist Device due to potential safety and performance concerns.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/max-mobility-permobil-issues-nationwide-recall-smartdrive-speed-control-dial-due-motor-being

 
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Neonatal Incubator Correction: GE HealthCare Updates Use Instructions for GE HealthCare Giraffe OmniBed Carestation and Incubator Carestation due to Risk of Patient Formaldehyde Exposure

Murilo Freitas - 05:00, 15 de January de 2025171
Newly manufactured Giraffe Omnibed and Incubator Carestations for neonates may put off higher than expected formaldehyde levels for the first week of use.

http://www.fda.gov/medical-devices/medical-device-recalls/neonatal-incubator-correction-ge-healthcare-updates-use-instructions-ge-healthcare-giraffe-omnibed

 
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FDA Proposes Significant Step Toward Reducing Nicotine to Minimally or Nonaddictive Level in Cigarettes and Certain Other Combusted Tobacco Products

Murilo Freitas - 14:08, 14 de January de 2025175

FDA Proposes Significant Step Toward Reducing Nicotine to Minimally or Nonaddictive Level in Cigarettes and Certain Other Combusted Tobacco Products
http://www.fda.gov/news-events/press-announcements/fda-proposes-significant-step-toward-reducing-nicotine-minimally-or-nonaddictive-level-cigarettes

 
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Endoscopic Vessel Harvesting (EVH) System Correction: Getinge and Maquet Cardiovascular Update Use Instructions for VasoView HemoPro 2 (VH-4000 and VH-4001) EVH Systems due to Risk for Bent or Detached Heater Wires and Silicone Peeling or Detaching During Use

Murilo Freitas - 05:00, 14 de January de 2025188
HemoPro EVH Systems have updated instructions related to bent/detached heater wires and peeling/detaching silicone during minimally invasive surgery.

http://www.fda.gov/medical-devices/medical-device-recalls/endoscopic-vessel-harvesting-evh-system-correction-getinge-and-maquet-cardiovascular-update-use

 
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