Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

NOMAD Pro2 Packaged X-Ray System, Part Number 08500021; NOMAD Pro2 Packaged X-Ray System Black, P...

FDA Device Recall #Z-2717-2016 — Class II — July 18, 2016

Recall Summary

Recall Number Z-2717-2016
Classification Class II — Moderate risk
Date Initiated July 18, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Aribex Inc
Location Charlotte, NC
Product Type Devices
Quantity 16,871

Product Description

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

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.

Distribution Pattern

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 / Code Information

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.

Other Recalls from Aribex Inc

Recall # Classification Product Date
Z-2716-2016 Class II NOMAD Pro Packaged X-Ray System, Part Number 08... Jul 18, 2016

Frequently Asked Questions

Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

More from Aribex Inc Recalls by Firm Recall Reasons Device Safety Stats