Data Foundry

Medical device recalls 2016

NOMAD Pro Packaged X-Ray System — Class II medical device recall Z-2716-2016

Terminated recall by Aribex Inc, reported 2016-09-14, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had appeared to "

Recall numberZ-2716-2016
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmAribex Inc, Charlotte, NC, United States
Recall initiated2016-07-18
Classified2016-09-02
Reported by FDA2016-09-14
Terminated2017-07-26
DistributedAK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY
Countries outside the USAE, AF, AR, AU, BE, BH, BM, BS, CH, CL, CN, DE, DK, FI, FR, GB, GR, GT, HK, HU, ID, IE, IL, IN, IQ, IT, JM, JP, KW, MA, MX, MY, NL, NZ, PH, PL, QA, SA, SE, SI, TH, TR, TT, VE, VN, ZA
Quantity16,871
Reason classesdevice malfunction
Model numbers08500009, 08500011, 08500013, 08500017, 08500019

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

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2716-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.