Recall Z-1915-2025 ยท CBK Ventilator, Continuous, Facility Use
Covidien
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
| Date | Jun 9, 2025 (initiated May 21, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Component design/selection |
| Action | 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 |
| Quantity | 5394 |
| Distribution | Worldwide - US Nationwide distribution including in the states of MA, CT, KS, OH, PR, NH, GA, WI, MS, VA, CO, TX, MN, AL, IA, NY, UT, NM, KY, RI, SD, PA, IA, CA, MO, HI, MI, IL, MT, NJ, TN, SC, FL, IN, AZ, ID, LA, WA, NC, MD, WY, NE, NV, ND, ME, AK, DE, OK, OR and the countries of Japan, Canada, S |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111146 | NEWPORT HT70 VENTILATOR Newport Medical Instruments, Inc., Dec 1, 2011 |