FDAJuly 12, 2022device

SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation

What to do

FDA enforcement status: Ongoing

Brands named

fujifilm healthcare americasfujifilmfujifilm healthcare

UPCs

0458029276669404573596200544

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C — Recall Details · AllClear