Recall Z-1192-2007 ยท CBK Ventilator, Continuous, Facility Use
Newport Medical Instruments Inc
Newport HT50 Ventilator (all Models)
| Date | Sep 19, 2007 (initiated Jul 31, 2007) |
| Status | Terminated |
| Reason | Battery Life: With use over time, the internal battery begins losing its ability to hold a charge resulting in shortened ventilator operation time. Specifically, Newport has received a number of reports concerning the internal battery not lasting as long as expected followed by ventilator shut down with less advance warning than when the battery was new. |
| Root cause | Other |
| Action | An Important Medical Device Correction Letter was issued on September 14, 2007 as a short term fix. The firm has submitted a long term correction as a supplement to its 510 K which is pending review by FDA. |
| Quantity | 8,160 |
| Distribution | Worldwide including USA, Algeria, Argentina, Armenia, Australia, Belgium, Bolivia, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cote D' Ivoire, Croatia, Cyprus, Dominican Republic, Ecuador, Egypt, El Salvador, England, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992133 | NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL Newport Medical Instruments, Inc., Aug 4, 2000 |