FDA Medical Device Recalls (openFDA)
Aribex Inc: 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
- Recall number
- Z-2717-2016
- Recalling firm
- Aribex Inc
- 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
- Status
- Terminated
- Initiated
- 2016-07-18
- Posted
- 2016-09-02
- Terminated
- 2017-07-26
- Reason
- 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.
- Root cause
- Other
- Action
- The firm sent a "FIELD ACTION NOTICE" to all affected customers.
- Quantity
- 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
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K081664"]
- PMA numbers
- not on file
- Product code
- EHD
- Firm FEI
- 1017522
- Firm city
- Charlotte
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28