Recall Z-2639-2016— Ziehm Imaging Inc

Name: FDA recall Z-2639-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-15

Class II · Terminated

Class II FDA medical device recall by Ziehm Imaging Inc, initiated 2016-04-15, terminated 2019-07-18. It names one FDA 510(k) clearance: K142740. Product: Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging. Reason: Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted..

Recalling firm: Ziehm Imaging Inc
Classification: Class II
Status: Terminated
Initiated: 2016-04-15
Terminated: 2019-07-18
Firm location: Orlando, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K142740 — Ziehm Vision RFD 3DZiehm Imaging GmbH·cleared 2015-04-06

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 3D Mobile C-arm for Mobile Fluoroscopic Imaging

Reason for recall

Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.

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