The Recall Desk
HighFDA (Devices)·Z-1171-2013·Announced 2013-05-08

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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a critical medical device (ventilator) where a power failure could lead to loss of life support, representing a risk-of-harm product where injury has not yet been reported.

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 indi

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

Same manufacturer · Newport Medical Instruments Inc

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