Newport HT50 Ventilator (all Models)
FDA device recall Z-1192-2007 · posted 2007-09-19 · Terminated
Recall details
- Recalling firm
- Newport Medical Instruments Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 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, E
- Date initiated
- 2007-07-31
- Date posted
- 2007-09-19
- Date terminated
- 2012-03-21
- Location
- Costa Mesa, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL (K992133) | Newport Medical Instruments, Inc. | 2000-08-04 |