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FDA (Device enforcement)Recalled 2013-04-05closedclass i

Newport Medical Instruments Inc: 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

Is my product affected?

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 individuals who require mechan

  • UPC 2096134110001
  • UPC 2292048120050

Check against the official notice below — it lists the full affected range.

What happened

Newport Medical Instruments is voluntarily recalling certain Power Pac batteries for its HT70 and HT70 Plus ventilators. The recall was initiated because customers reported that ventilators were alarming and switching to internal backup battery sooner than expected while operating on the Power Pac battery. The affected batteries have serial numbers ranging from 2096134110001 to 2292048120050 and include revisions C through F. Approximately 2,528 ventilators and 1,864 Power Pac batteries are involved in this recall, which has been distributed worldwide to numerous countries including throughout the United States and internationally to locations such as Canada, Australia, China, Brazil, and many others.

The recall source does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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 internal backup battery sooner than expected while the ventilator is being operated on Power Pac battery.

Details from the source

Reason for recall: 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 internal backup battery sooner than expected while the ventilator is being operated on Power Pac battery. Distribution: Worldwide Distribution - USA including US (AL, AR, AZ, CA, CO, CT, DE, FL, GA, lA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, WA, and WI. Internationally to Argentina, Australia, Bangladesh, Belgium, BoliVia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Ecuador, Egypt, France, Greece, Hong Kong, Quantity: 2528 ventilators and 1864 power pac batteries Lot/code info: Model number: HT70 and HT70 Plus Power Pac battery serial number range: 2096134110001 to 2292048120050, Rev. C through Rev. F

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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