Newport HT70 Ventilators Recalled for Control Board Failure Risk
Newport Medical Instruments is recalling 72 HT70 and HT70 Plus ventilators because a control board failure may cause the device to stop ventilating.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a critical life-support device that may stop ventilating patients due to a structural component failure, posing a significant risk of serious injury or death, which aligns with the 'Severe' criteria for significant injury reports or structural defects in high-risk devices.
Plain-English summary
Newport Medical Instruments Inc. is recalling 72 units of the HT70 and HT70 Plus ventilators. These devices are intended to provide mechanical ventilatory support for infant, pediatric, and adult patients weighing at least 5 kg in hospital, sub-acute, emergency, home care, and transport settings.
The recall is due to a component failure on the control board. This defect may cause the ventilator to emit a continuous high-priority alarm and stop ventilating the patient. The affected units were distributed worldwide, including in the United States, Brazil, Chile, Egypt, France, Hong Kong, India, Japan, Norway, the Philippines, and South Africa.
Healthcare facilities and users should identify affected units by checking the serial numbers listed in the official recall notice. Users should contact Newport Medical Instruments for instructions on how to address the defect.
The recalled product
- Product
- 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…
- Manufacturer
- Newport Medical Instruments Inc
- Category
- Medical Device — Ventilator
- Affected units
- 72
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- 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
Distribution
Distributed nationwide across the United States.
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