Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. Product Usage: The HT70 ventilator system is i
FDA device recall Z-2250-2012 · posted 2014-04-14 · Terminated
Recall details
- Recalling firm
- Newport Medical Instruments Inc
- Reason for recall
- May emit a continuous high priority alarm and the ventilator may stop ventilating, due to a component failure on the control board.
- Action taken
- Newport Medical sent an Urgent Field Correction Notice letter dated August 3, 2012 to all affected customers, via DHL and FedEx courier services. The letter identified the affected product, reason for recall and actions to be taken. Customers were instructed to immediately stop using the affected ventilator and retrieve the replacement kit provided free of charge. In addition, the letter states that if the product was further distributed, to contact their customers and notify them of the recall. Customers were asked to complete and return the enclosed Replacement form as replacements are completed. For questions contact Newport Medical Technical Support Department at 800-451-3111, extension 282, for U.S. customers; 714-427-5811, extension 500, for international customers.".
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 72
- Distribution
- Worldwide distribution: USA (nationwide) and countries of: Brazil, Chile, Egypt, France, Hong Kong, India, Japan, Norway, Philippines and South Africa.
- Date initiated
- 2012-08-03
- Date posted
- 2014-04-14
- Date terminated
- 2014-04-14
- Location
- Costa Mesa, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEWPORT HT70 VENTILATOR (K111146) | Newport Medical Instruments, Inc. | 2011-12-01 |
| NEWPORT HT70 FAMILY OF VENTILATORS (K090888) | Newport Medical Instruments, Inc. | 2009-11-18 |