SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
Enforcement
- Recall Number
- Z-1748-2022
- Event ID
- 90751
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- FUJIFILM Healthcare Americas Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- September 21, 2022
- Initiation Date
- July 12, 2022
- Classification Date
- September 15, 2022
- Address
- 81 Hartwell Ave Ste 300, Lexington, MA, 02421-3160, United States
Description
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
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
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US Nationwide Distribution
46 units