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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 20
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by FUJIFILM Healthcare Americas Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · FUJIFILM Healthcare Americas Corporation
See all →- ModerateFujifilm Synapse PACS Software Recalled for Inaccurate Ruler Measurements
FDA (Devices) · 2026-09-02
- HighX-ray systems recalled over welded contactor contacts that may overheat
FDA (Devices) · 2026-02-11
- HighRadiography suites recalled because X-ray tube mounting shaft may break
FDA (Devices) · 2025-10-15
- ModerateASPIRE Cristalle mammography systems shipped with unapproved slabbing software enabled
FDA (Devices) · 2025-08-06
- HighSynapse PACS Software incorrect patient age calculation for infants
FDA (Devices) · 2025-03-26
Same hazard · radiation exposure
See all →- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- HighPhilips Recalls IQon Spectral CT Systems Due to Radiation Issue
FDA (Devices) · 2026-09-09
- HighPhilips Brilliance CT Systems Recalled for Unintended Radiation Issue
FDA (Devices) · 2026-09-09
- HighPhilips CT Systems Recalled for Unintended Radiation Performance Issues
FDA (Devices) · 2026-09-09
- HighPhilips CT Systems Recalled for Unintended Radiation Performance Issues
FDA (Devices) · 2026-09-09
Similar recalls
- HighFujifilm Recalls Mammography Software Due to Potential Image Overwrite Error
FDA (Devices) · 2018-02-28
- HighAzurion imaging systems recalled over two software issues affecting imaging
FDA (Devices) · 2026-01-28
- HighSiemens Fluoroscopic X-Ray Systems Recalled for Radiation Malfunction
FDA (Devices) · 2013-12-04
- HighMRI System Software Defect Causes Missing Image Slices
FDA (Devices) · 2021-10-27
- HighMedical Imaging Software Bug May Cause Incorrect X-ray Exposure
FDA (Devices) · 2021-09-08
- HighSiemens Cios Alpha X-ray system software defect may cause patient misdiagnosis
FDA (Devices) · 2023-11-08