Recall record at a glance
| Official record | Z-2716-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Aribex Inc. |
| Report date | Sep 14, 2016 |
| Recall initiation date | Jul 18, 2016 |
| Quantity | 16,871 |
| Location | Charlotte, NC, United States |
Official product description
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
Why the product was recalled
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.
Distribution information
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
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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