Recall Z-2716-2016 ยท EHD Unit, X-Ray, Extraoral With Timer
Aribex Inc
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
| Date | Sep 2, 2016 (initiated Jul 18, 2016) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081664 | NOMAD PRO X-RAY SYSTEM Aribex, Inc., Jun 23, 2008 |