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U.S. Department of Health and Human Services

Class 2 Device Recall NOMAD Pro2 Packaged XRay System

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  Class 2 Device Recall NOMAD Pro2 Packaged XRay System see related information
Date Initiated by Firm July 18, 2016
Date Posting Updated September 02, 2016
Recall Status1 Terminated 3 on July 26, 2017
Recall Number Z-2717-2016
Recall Event ID 74975
510(K)Number K081664  
Product Classification Unit, x-ray, extraoral with timer - Product Code EHD
Product NOMAD Pro2 Packaged X-Ray System, Part Number 08500021; NOMAD Pro2 Packaged X-Ray System Black, Part Number 08500022; NOMAD Pro2 Vet Packaged X-Ray System, Part Number 08500023; NOMAD Pro2 Vet Packaged X-Ray System Black, Part Number 08500024; NOMAD Pro2 Packaged X-Ray System, GBL, Part Number 08500025 and Part Number 08500026; NOMAD Pro2 Packaged X-Ray System, GLB, Vet, Part Number 08500027 and Part Number 08500028; NOMAD Pro2 Package X-Ray System, GLB, Black, Part Number 08500029
Code Information Part Number 08500021 - Serial Number Range XD-100921-05 - XD-150109-11, 10000 - 20811, XD-140929-39 - XD-150123-20; Part Number 08500022 - Serial Number Range XE-130528-03 - XE-150123-38, 10000 - 20541, XE-140908-32 - XE-150123-40; Part Number 08500023 - Serial Number Range XF-121008-05 - XF-150205-03, 10003 - 20032, XE-150205-01; Part Number 08500024 - Serial Number Range XG-130520-01 - XG-141210-05, 1000 - 20019; Part Number 08500025 - Serial Number Range XI-140303-02 - XI-150210-9, XI-150202-04 - XI-150210-19; Part Number 08500026 - Serial Number Range 10039 - 20041; Part Number 08500027 - Serial Number Range 1000 - 20006, Part Number 08500028 - Serial Number Range 10000 - 20030; Part Number 08500029 - Serial Number Range 10000.
Recalling Firm/
Manufacturer
Aribex Inc
11727 Fruehauf Dr
Charlotte NC 28273-6507
For Additional Information Contact Erika 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
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
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = EHD and Original Applicant = ARIBEX, INC.
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