Z-2716-2016Class II

NOMAD Pro Packaged X-Ray System, Part Number 08500009; NOMAD Pro Vet Packaged X-Ray System, Part Number...

Name: Z-2716-2016 NOMAD Pro Packaged X-Ray System, Part Number 08500009; NOMAD Pro Vet Packaged X-Ray System, Part Number...
Creator: Aribex Inc
Published: 2016-07-18
License: https://open.fda.gov/license/

KaVo Dental Technologies, LLC / initiated 2016-07-18 / Terminated

FDA source

Aribex Inc began a recall of NOMAD Pro Packaged X-Ray System, Part Number 08500009; NOMAD Pro Vet Packaged X-Ray System, Part Number 08500011; NOMAD Pro Packaged X-Ray System - Europe... on 2016-07-18. FDA classified it as Class II and gives the reason as "Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had appeared to "overheat", "melt", "smoke" and/or "ignite." Investigation found that the internal lithium ion batteries had...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2716-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-18
Posted: 2016-09-02
Terminated: 2017-07-26
Recalling firm: KaVo Dental Technologies, LLC
Product: NOMAD Pro Packaged X-Ray System, Part Number 08500009; NOMAD Pro Vet Packaged X-Ray System, Part Number 08500011; NOMAD Pro Packaged X-Ray System - Europe, Part Number 08500013; NOMAD Pro X-Ray System, Remote Config., Part Number 08500017; NOMAD Pro Packaged X-Ray System JP, Part Number 08500019
Product code: EHD Unit, X-Ray, Extraoral With Timer
Reason for recall: Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had appeared to "overheat", "melt", "smoke" and/or "ignite." Investigation found that the internal lithium ion batteries had entered into a thermal runaway condition as a result of a short circuit on the battery pack PCB.
FDA root cause: Other
Action: The firm sent a "FIELD ACTION NOTICE" to all affected customers.
Quantity in commerce: 16,871
Distribution: AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA. HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY , Puerto Rico, Afghanistan, Argentina, Australia, Bahamas, Bahrain, Belgium, Bermuda, Chile, China, Columbia, Denmark, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Kuwait, Malaysia, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Saudi Arabia, Papua New Guinea, Philippines, Poland, Qatar, Saudi Arabia, Slovenia, South Africa, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, UAE, United Kingdom, Venezuela, Vietnam
Product codes and lots: Part Number 08500009 - Serial Number Range BX-011008-01 - XB-141219049; Part Number 08500011- Serial Number Range XC -090305-03 - XC-140312-02; Part Number 08500013 - Serial Number Range XB-110411-01 - XB-140616-13; Part Number 08500017 - Serial Number Range XB-120911-04 - XB-141210-50; Part Number 08500019 - Serial Number Range XB-120517-09 - XB-121212-24

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2716-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2716-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-02
Z-2717-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-02

Product code EHD

K081664Class IINomad Pro X-Ray SystemAribex, Inc. / cleared 2008-06-23

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)