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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64851

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
April 05, 2013
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Newport Medical Instruments Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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 mechanical ventilation through invasive or non-invasive interfaces.

Z-1171-2013
Recall number
Z-1171-2013
Initiated
April 05, 2013
Classification
Class I
Status
Terminated
Quantity
2528 ventilators and 1864 power pac batteries

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model number: HT70 and HT70 Plus Power Pac battery serial number range: 2096134110001 to 2292048120050, Rev. C through Rev. F

Distribution pattern

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, Hungary, India, Indonesia, Israel, Ireland, Italy, Japan, Kazakhstan, Kosova, Lebanon, Lithuania, Malaysia, Mexico, Nambia, Nepal, Norway, Oman, Paraguay, Peru, Philippines, Poland, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Viet Nam.

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