FDA-Device2016-05-11Class II

Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU

Fujifilm Medical Systems U.S.A., Inc.
Hazard

Reports of failure of the device's power supply.

Sold states
Nationwide Distribution.
Affected count
2,062 devices
Manufactured in
419 West Ave, Stamford, CT, United States
Products
Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1599-2016

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