Recall Z-1748-2022— FUJIFILM Healthcare Americas Corporation
Class II · Ongoing
Class II FDA medical device recall by FUJIFILM Healthcare Americas Corporation, initiated 2022-07-12. It names one FDA 510(k) clearance: K213829. Product: SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C. Reason: 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.
- Recalling firm
- FUJIFILM Healthcare Americas Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-07-12
- Firm location
- Lexington, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.