Surpria 64 Software Error May Prevent Image Reconstruction During Scanning
Surpria 64 CT scanner software versions V3.11 and V3.22 may encounter errors that prevent image reconstruction, requiring repeat scans that expose patients to additional radiation. 16 units nationwide are affected.
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: FDA Class II medical device with potential to expose patients to unnecessary radiation through diagnostic failure requiring repeat imaging. No illnesses or injuries have been reported, placing this in the risk-of-harm category without reported injuries.
Plain-English summary
FUJIFILM Healthcare Americas Corporation has recalled Surpria 64 medical imaging software versions V3.11 and V3.22. The software may encounter error codes 00003050 or 00003052 during scanning operations, which triggers a critical diagnostic failure.
When these errors occur, the captured images cannot be reconstructed and raw data will not be displayed in the work list. As a consequence, additional scanning may be required to obtain properly reconstructed diagnostic images, thereby exposing patients to unnecessary additional radiation.
The recall affects 16 units of Surpria 64 imaging systems distributed nationwide across the United States.
The recalled product
- Product
- Surpria 64: Software Version V3.11, V3.22
- Manufacturer
- FUJIFILM Healthcare Americas Corporation
- Affected units
- 16
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.
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