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NOMAD Pro Packaged X-Ray System, Part Number 08500009; NOMAD Pro Vet Packaged X-Ray System, Part ...

FDA Device Recall #Z-2716-2016 — Class II — July 18, 2016

Recall Summary

Recall Number Z-2716-2016
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 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

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 08500009 - Serial Number Range BX-011008-01 - XB-141219049; Part Number 08500011- Serial Number Range XC -090305-03 - XC-140312-02; Part Number 08500013 - Serial Number Range XB-110411-01 - XB-140616-13; Part Number 08500017 - Serial Number Range XB-120911-04 - XB-141210-50; Part Number 08500019 - Serial Number Range XB-120517-09 - XB-121212-24

Other Recalls from Aribex Inc

Recall # Classification Product Date
Z-2717-2016 Class II NOMAD Pro2 Packaged X-Ray System, Part Number 0... 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.

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