Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients.

FDA device recall Z-1064-2015 · posted 2015-02-09 · Terminated

Recall details

Recalling firm

Virtual Imaging, Inc.

Reason for recall

There is a potential for unintended and erratic motion.

Action taken

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 technicalsupport@vifla.com.

Root cause

Component design/selection

Status

Terminated

Product code

IZL

Quantity affected

316 (US) 6 (Foreign)

Distribution

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 A

Date initiated

2014-09-22

Date posted

2015-02-09

Date terminated

2018-02-20

Location

Boca Raton, FL

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