Recall Z-1064-2015 ยท IZL System, X-Ray, Mobile
Virtual Imaging, Inc.
Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients.
| Date | Feb 9, 2015 (initiated Sep 22, 2014) |
| Status | Terminated |
| Reason | There is a potential for unintended and erratic motion. |
| Root cause | Component design/selection |
| 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 technicalsupport@vifla.com. |
| Quantity | 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 Army facility in South Korea; and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101517 | SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY Sedecal., Sa., Aug 5, 2011 |