Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients.
FDA Recall Z-1064-2015 · Posted 2015-02-09
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Recalling FirmVirtual Imaging, Inc.
Recall StatusTerminated
Product CodeIZL
Date Initiated2014-09-22
Date Terminated2018-02-20
Product Quantity316 (US) 6 (Foreign)
Reason for Recall
There is a potential for unintended and erratic motion.
Firm Action
Virtual Imaging sent an FIELD CORRECTION NOTIFICATION letter dated September 22, 2014, to all affected customers. The letters advised direct accounts that a Virtual Imaging Field Engineer with contact them to schedule an appointment for the replacement of the Digital Motion Control Kit. Customers with any concerns about this situation can contact Virtual Imaging's Technical Support at 561-893-8500 or via e-mail at [email protected].
Root Cause
Component design/selection
Distribution Pattern
USA (nationwide) to the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV) + US Army facility in South Korea; and the country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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