The Recall Desk
HighFDA (Devices)·Z-1748-2022·Announced 2022-09-21

SCENARIA View software error may require additional patient radiation exposure

SCENARIA View imaging software errors prevent image reconstruction, which may require additional scans and expose patients to unnecessary radiation.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall involving imaging software errors that may necessitate additional diagnostic scans, exposing patients to unintended radiation. No patient injuries or illnesses have been reported, making this a theoretical risk-of-harm scenario.

Plain-English summary

SCENARIA View imaging software (versions V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C) is the subject of this recall. Certain software versions may produce Error 00003050 or 00003052 during image scanning, which prevents proper image reconstruction and prevents Raw Data from displaying in the work list.

When these errors occur, the affected images cannot be reconstructed. Healthcare facilities may need to perform additional imaging scans to obtain usable diagnostic images, which exposes patients to additional radiation exposure.

46 units of the affected software were distributed nationwide throughout the United States.

Healthcare facilities using the affected software versions should contact FUJIFILM Healthcare Americas Corporation for updated software or remediation guidance.

The recalled product

Product
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
Manufacturer
FUJIFILM Healthcare Americas Corporation
Category
Medical Device — Diagnostic Imaging Software
Hazard
  • radiation-exposure
  • software-error

Distribution

Distributed nationwide across the United States.

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