Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. Product Usage: The...
FDA Device Recall #Z-2250-2012 — Class I — August 3, 2012
Recall Summary
| Recall Number | Z-2250-2012 |
| Classification | Class I — Serious risk |
| Date Initiated | August 3, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Newport Medical Instruments Inc |
| Location | Costa Mesa, CA |
| Product Type | Devices |
| Quantity | 72 |
Product Description
Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. Product Usage: The HT70 ventilator system is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs.). The HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. The HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
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.
Distribution Pattern
Worldwide distribution: USA (nationwide) and countries of: Brazil, Chile, Egypt, France, Hong Kong, India, Japan, Norway, Philippines and South Africa.
Lot / Code Information
Model Number: HT70 and HT70 Plus. Serial numbers: N12HT700514226 to N12HT700514231, N12HT700514233 to N12HT700514236, N12HT700514238 to N12HT700614280, N12HT700614282 to N12HT700614299, N12HT700614301 to N12HT700614309, N12HT720410266 to N12HT720410268, N12HT720410271, N12HT720410273, N12HT720410282, N12HT720410283, N12HT720410286, N12HT720410288, N12HT720410289, N12HT720410290, N12HT720410294 to N12HT720510300, N12HT720510302, N12HT720510322 to N12HT720510330, N12HT720510332 to N12HT720510344,
Other Recalls from Newport Medical Instruments Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1874-2017 | Class I | Newport Medical HT70 and HT70- Plus Ventilators... | Mar 30, 2017 |
| Z-1171-2013 | Class I | Newport Medical Instruments HT70 and HT70 Plus... | Apr 5, 2013 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.