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Recall Observatory FDA recall evidence

Device product

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

Z-1599-2016

April 01, 2016

Class II

Product summary

Firm
Fujifilm Medical Systems U.S.A., Inc.
Event
Event 73668
Status
Terminated
Classification
Class II
Quantity
2,062 devices
Official record key
device-enforcement:Z-1599-2016

Official wording

Reason: Reports of failure of the device's power supply.

Code information: All serial numbers.

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Reports of failure of the device's power supply.