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Ultroid Technologies, Inc. recalls Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable Probes
Recalled December 28, 2016 · FDA recall Z-0783-2017 · Ultroid Technologies
Hazard
Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation) · FDA Class II
Units
62 units
Sold at
AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, KS, LA, MD, ME, MI, MN, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA and Puerto Rico Asturias, Australia, Chile, Greece, Hong Kong, India, Indonesia, Iraq, Japan, Kuwait, Malaysia, Mexico, Nigeria, Qatar, Russia, Slovenia, Spain, Syria, Trinidad, Turkey, UAE, UK, and Vietnam
Description
Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation)
Product
Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable Probes
Manufacturer(s)
Ultroid Technologies, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →