Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU. Newport HT70Plus Ventilator, REF: HT70PM-ES-EU, HT70PM-ES-NA, HT70PM-JP-NA, HT70PM-PT-BR, HT70PM-SY-AS, DLHT70PM-WW-NA, HT70PM-SY-NA, HT70PM-SY-UK, HT70PM-WW-EU, HT70PM-WW-UK, HT70PM-SY-EU, HT70PM-WW-NA. HT70-2 CONTROL BOARD ROHS, REF: GR-PCB3252A. HT70-2 CONTROL BOARD ROHS X1, REF: GR105796. HT70P CONTROL BOARD ROHS X1, REF: GR105795. HT70 Conversion Kit, REF: GRFSKHT70M-2.

Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation, or the shutdown alert alarm fails to alarm effectively during shut down, which may result in respiratory failure, hypoventilation, low oxygen saturation, hypoxia, treatment delay.

On 05/21/2025 recall notices were mailed and/or emailed to customers who were asked to do the following: Healthcare providers with patients currently ventilated with affected ventilators should assess overall risk and appropriate timing for device replacement. - Patient connected to a ventilator requires the constant attention of trained caregivers to the patient's condition. - Have an alternate power source and means of ventilation available when the ventilator is in use. - Use appropriate monitors to ensure sufficient oxygenation and ventilation when ventilator is in use. - If the patient is not responding to ventilation appropriately, the patient should be taken off the ventilator immediately and connected to an alternate method of ventilation. Contact the patient's health care provider/physician. - Follow Patient Set-up Procedure described in Operator's Manuals. Medtronic is not correcting these issues on affected ventilators or service parts and will no longer service affected ventilators identified in this notification. -If affected ventilator or service part is currently in use, remove and replace it with an alternate means of ventilation. After completing the transition, quarantine all affected ventilators and service parts and dispose. Patients are asked to return affected devices to their healthcare provider. Complete/return the Acknowledgement Form via email to [email protected]. Questions or concerns contact firm at 1-800-255-6774 Distribute notice to all relevant personnel within your organization and any organizations where ventilators or service parts may have been transferred or distributed. Provide the enclosed patient letter to any of your patients using this ventilator in the home care setting to inform them of this recall. On 8/11/2026, recall notices listing additional affected devices were mailed and/or emailed to customers.