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U.S. Department of Health and Human Services

Class 2 Device Recall NOMAD Pro Packaged XRay System

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 Class 2 Device Recall NOMAD Pro Packaged XRay Systemsee related information
Date Initiated by FirmJuly 18, 2016
Date PostedSeptember 02, 2016
Recall Status1 Terminated 3 on July 26, 2017
Recall NumberZ-2716-2016
Recall Event ID 74975
510(K)NumberK081664 
Product Classification Unit, x-ray, extraoral with timer - Product Code EHD
ProductNOMAD 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
Code Information 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
FEI Number 1017522
Recalling Firm/
Manufacturer		 Aribex Inc
11727 Fruehauf Dr
Charlotte NC 28273-6507
For Additional Information ContactErika Martin
704-587-7241
Manufacturer 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 Determined
Cause 2		Other
ActionThe firm sent a "FIELD ACTION NOTICE" to all affected customers.
Quantity in Commerce16,871
DistributionAL, 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = EHD
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