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Terminated

Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging

FDA Recall Z-2640-2016 · Posted None

Recalling FirmZiehm Imaging Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2016-04-15
Date Terminated2019-07-18
Product Quantity14 devices

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.

Firm Action

Ziehm Imaging, Inc planned action to bring these defects into compliance: 1. You will contact customers and initiate a software update to correct the defects. 2. You will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. For further questions, please call (866) 949-4346.

Root Cause

Device Design

Distribution Pattern

US Distribution including Puerto Rico and to the states of :FL, GA, VA,MA. ME, MI, NY, NJ, PA, RI, IL, TX, AZ, CA, NV, UT, and WA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K132904ZIEHM VISION RFDZiehm Imaging GmbH · 2013-12-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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