Newport Medical Instruments Recalls HT70 Ventilator Power Pac Batteries
Newport Medical Instruments is voluntarily recalling HT70 and HT70 Plus ventilator Power Pac batteries because they may cause the ventilator to alarm and switch to backup power sooner than expected.
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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Newport Medical Instruments is conducting a voluntary recall on certain Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries due to customer reports of Newport HT70 and HT70 Plus ventilators alarming and going to…"
Plain-English summary
Newport Medical Instruments Inc is conducting a voluntary recall of certain HT70 and HT70 Plus ventilator Power Pac batteries. The recall involves 2,528 ventilators and 1,864 Power Pac batteries. The affected Power Pac batteries have serial numbers ranging from 2096134110001 to 2292048120050, Rev. C through Rev. F.
The recall is being conducted due to customer reports that the HT70 and HT70 Plus ventilators alarmed and went to internal backup battery sooner than expected while being operated on the Power Pac battery. The HT70 and HT70 Plus ventilator systems are intended to provide continuous or intermittent positive pressure mechanical ventilatory support for individuals who require mechanical ventilation through invasive or non-invasive interfaces.
The affected products were distributed worldwide, including in the United States and numerous international locations. Consumers and healthcare facilities should contact Newport Medical Instruments for further instructions regarding the recall.
The recalled product
- Product
- Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model number: HT70 and HT70 Plus. The HT70 and HT70 Plus ventilator systems are intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of…
- Manufacturer
- Newport Medical Instruments Inc
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 (1)
- Rev. C through Rev. F
Distribution
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