The Recall Desk
HighFDA (Devices)·Z-1749-2022·Announced 2022-09-21

FUJIFILM Surpria Imaging Software May Fail During Scanning

Surpria software versions V3.11 and V3.22 may encounter processing errors that prevent image reconstruction, potentially requiring additional scans and exposing patients to unnecessary radiation.

What this means for you

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 recall of imaging software that may fail during scanning and require repeat scans, exposing patients to additional radiation. No illnesses or injuries have been reported, but the defect creates a risk-of-harm scenario where injury has not yet been reported.

Plain-English summary

FUJIFILM Healthcare Americas Corporation is recalling Surpria imaging software versions V3.11 and V3.22 used in medical imaging systems. The software contains a defect that may prevent proper image processing during scanning operations.

During scanning, software errors 00003050 or 00003052 may occur. When these errors happen, captured images fail to reconstruct and raw data does not display in the work list. This malfunction may require repeat scanning to properly capture and process the images.

Repeat scanning is a patient safety concern because it exposes patients to additional radiation. This recall affects approximately 20 units of affected software distributed nationwide to medical imaging facilities.

The recalled product

Product
Surpria: Software Version V3.11, V3.22
Manufacturer
FUJIFILM Healthcare Americas Corporation
Category
Medical Device — Diagnostic Imaging Software
Hazard
  • radiation-exposure
  • imaging-failure

Distribution

Distributed nationwide across the United States.

Related recalls

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