Z-1171-2013Class I

Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model number: HT70 and HT70...

Name: Z-1171-2013 Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model number: HT70 and HT70...
Creator: Newport Medical Instruments Inc
Published: 2013-04-05
License: https://open.fda.gov/license/

Newport Medical Instruments, Inc. / initiated 2013-04-05 / Terminated / root cause: design

FDA source

Newport Medical Instruments Inc began a recall of 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... on 2013-04-05. FDA classified it as Class I and 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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1171-2013
Classification: Class I
Status: Terminated
Initiated: 2013-04-05
Posted: 2013-04-26
Terminated: 2015-03-10
Recalling firm: Newport Medical Instruments, Inc.
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 individuals who require mechanical ventilation through invasive or non-invasive interfaces.
Product code: CBK Ventilator, Continuous, Facility Use
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: Newport Medical Instruments sent an Urgent Medical Device Recall letter dated April 4, 2013, via FedEx to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers who sold the affected product to another party, or placed the affected product with a patient or healthcare provider were instructed to immediately inform the other party, patient, or healthcare provider of this action and provide them with a copy of the letter. If customers were using the affected product, they should ensure that an alternate source of power is available nearby. Customers were instructed to report any issues with Newport" HT70 and HT70 Plus ventilators or Power Pac batteries to the Technical Support group to ensure proper device reporting procedures are followed. Please call 800-451-3111, extension 500, for U.S. customers; and 714-427-5811, extension 500 for international customers and you will be given further instructions). For questions regarding this recall call 714-427-5811, ext 344. A press release was issued by the firm on 04/18/13.
Quantity in commerce: 2528 ventilators and 1864 power pac batteries
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, 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.
Product codes and lots: Model number: HT70 and HT70 Plus Power Pac battery serial number range: 2096134110001 to 2292048120050, Rev. C through Rev. F

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1171-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1171-2013	Class I	Terminated	Voluntary: Firm initiated	2013-05-08	2013-04-26

Product code CBK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)