NOMAD Pro Packaged X-Ray System, Part Number 08500009; NOMAD Pro Vet Packaged X-Ray System, Part Number 08500011; NOMAD
FDA device recall Z-2716-2016 · posted 2016-09-02 · Terminated
Recall details
- Recalling firm
- Aribex Inc
- 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.
- Action taken
- The firm sent a "FIELD ACTION NOTICE" to all affected customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- EHD
- Quantity affected
- 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, W
- Date initiated
- 2016-07-18
- Date posted
- 2016-09-02
- Date terminated
- 2017-07-26
- Location
- Charlotte, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NOMAD PRO X-RAY SYSTEM (K081664) | Aribex, Inc. | 2008-06-23 |