Recall Z-0568-2014— Ziehm Imaging Inc

Name: FDA recall Z-0568-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-21

Class II · Terminated

Class II FDA medical device recall by Ziehm Imaging Inc, initiated 2013-11-21, terminated 2014-06-23. It names one FDA 510(k) clearance: K083545. Product: Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging. Reason: Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices..

Recalling firm: Ziehm Imaging Inc
Classification: Class II
Status: Terminated
Initiated: 2013-11-21
Terminated: 2014-06-23
Firm location: Orlando, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K083545 — ZIEHM VISION RFDZiehm Imaging, Inc.·cleared 2009-05-15

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

Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging

Reason for recall

Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

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