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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 46
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by FUJIFILM Healthcare Americas Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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