Severity
Moderate
FDA Devices recall · Reported September 21, 2022
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 …
Fujifilm Healthcare Americas Corporation recalled SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C - a moderate-severity action.
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C was recalled by Fujifilm Healthcare Americas Corporation in September 21, 2022. Reason: Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the …. Check the official notice for the remedy. Verify recall #Z-1748-2022 with the FDA Devices before acting.
The recall
Fujifilm Healthcare Americas Corporation issued this moderate-severity FDA Devices recall-Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the ….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1748-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1748-2022) was formally reported on September 21, 2022, with the manufacturer initiating the action on July 12, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Fujifilm Healthcare Americas Corporation is listed as the recalling firm, operating out of Lexington, MA. Federal records list the affected scope as 46 units.
The documented reason for this recall is: 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 capt… Distribution data in the federal record shows the product reached: US Nationwide Distribution. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
46 units
Related Recalls
6
3 from same agency
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
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1748-2022 |
| Date reported | September 21, 2022 |
| Date initiated | July 12, 2022 |
| Recalling firm | Fujifilm Healthcare Americas Corporation |
| Firm location | Lexington, MA |
| Affected scope | 46 units |
| Distribution | US Nationwide Distribution |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 21, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.