SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
Reported: September 21, 2022 Initiated: July 12, 2022 #Z-1748-2022
Product Description
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
Reason for Recall
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
Details
- Recalling Firm
- FUJIFILM Healthcare Americas Corporation
- Units Affected
- 46 units
- Distribution
- US Nationwide Distribution
- Location
- Lexington, MA
Frequently Asked Questions
What product was recalled? ▼
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C. Recalled by FUJIFILM Healthcare Americas Corporation. Units affected: 46 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 21, 2022. Severity: Moderate. Recall number: Z-1748-2022.
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