32 results

• Philips Ventilator Recall Issued Due to Aerosol Deposits From In-Line Nebulizer Placements

  November 21, 2024

  Irvin Jackson

  The FDA has determined that urgent correction letters sent out by Philips to address problems with oxygen flow in certain ventilators constitutes a class I recall, meaning the agency believes the problems can result in serious patient injuries or deaths.

• Philips Recalls Trilogy Evo Ventilators for Lung Injury Risks When Used With Nebulizers

  October 8, 2024

  Darian Hauf

  Philips Respironics has issued a recall of several Trilogy Evo ventilator models used in conjunction with nebulizers over the risk of device malfunctions and lung injuries.

• ParaPAC Plus Ventilator Recall Issued Due to Risk of Serious Injury or Death

  September 23, 2024

  Darian Hauf

  Smiths Medical has issued an urgent medical device notification for paraPAC plus ventilators, due to a risk that loose or detached outlet connectors may cause serious adverse consequences for patients.

• Vivo 45 LS Ventilator Recall Issued Over Formaldehyde Exposure Risks

  August 12, 2024

  Michael Adams

  Over 8,000 Breas Vivo ventilators have been recalled due to the risk of exposing users to formaldehyde, which may cause neurological side effects and respiratory injuries.

• Baxter Life2000 Ventilator Recall Issued Over Battery Charging Problems Linked To Patient Injury

  July 17, 2024

  Grace Muller

  About 2,500 Baxter Life2000 ventilators are being recalled because the battery charging dongle can fail, resulting in patients not receiving life-sustaining oxygen, putting them at risk of severe injury and death.

• Philips OmniLab Advanced+ Ventilator Recall Issued Over Loss of Therapy Risks

  July 1, 2024

  Irvin Jackson

  The FDA has indicated that a change of instructions for the Philips OmniLab Advanced+ to prevent loss of therapy constitutes a class I recall notice, following reports of more than a dozen injuries and one patient death.

• Philips Trilogy EVO Ventilator Recall Issued Due to Software-Related Power Malfunction Risk

  May 14, 2024

  Irvin Jackson

  About 100,000 Trilogy EVO ventilators are being recalled due to a software error which can lead to the devices ceasing to function for patients in need of life-saving oxygen supplementation.

• Hamilton Ventilator Recall Issued Over Short Circuit, Capacitor Leak Risks

  October 19, 2023

  Katherine McDaniel

  The FDA warns that the recalled Hamilton ventilators can short circuit and fail, which could put patients at risk of severe injury and death.

• Hamilton Ventilator Recall Issued Over Risk of Sudden Failures Due to Software Defect

  August 31, 2023

  Katherine McDaniel

• Draeger Ventilator Recall Issued Over Toxic Cancer-Causing Foam Particles

  August 28, 2023

  Irvin Jackson

  The FDA has classified a Carina ventilator PE-PUR foam warning as a class I recall, indicating the breathing devices could put children in particular at an increased risk of cancer and death.