Recall Z-1064-2015— Virtual Imaging, Inc.

Name: FDA recall Z-1064-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-22

Class II · Terminated

Class II FDA medical device recall by Virtual Imaging, Inc., initiated 2014-09-22, terminated 2018-02-20. It names one FDA 510(k) clearance: K101517. Product: Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients.. Reason: There is a potential for unintended and erratic motion..

Recalling firm: Virtual Imaging, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-09-22
Terminated: 2018-02-20
Firm location: Boca Raton, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K101517 — SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAYSedecal., Sa.·cleared 2011-08-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

There is a potential for unintended and erratic motion.

Data sourced from openFDA. This site is unofficial and independent of the FDA.