FDA-Device2017-05-24Class II
Ziehm Imaging solo FD Mobile Fluoroscopic C-arm
Ziehm Imaging Inc
Hazard
During Ziehm Imaging GmbH FDA inspection, the label for the Collimator and X-ray Control panel was missing the manufacturer date as part of the identification for certified component
Sold states
US Distribution to the states of : FL and CA. No devices listed in this recall where distributed any foreign /military/government consignees from the U.S.A.
Affected count
US - 2 systems
Manufactured in
6280 Hazeltine National Dr Ste 100, Orlando, FL, United States
Products
Ziehm Imaging solo FD Mobile Fluoroscopic C-arm
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1893-2017Don't want to check this manually?
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