Fujifilm Recalls Synapse PACS Software Due to Patient Data Display Errors
Fujifilm is recalling Synapse PACS Software versions 5.1 and higher because it may display incorrect patient information or PET/CT values.
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: The recall involves a medical device software defect that could lead to incorrect patient data or diagnostic values, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling Synapse PACS Software versions 5.1 and higher. The recall involves 235 units of the software, which were distributed to medical facilities nationwide throughout the U.S.
The recall was initiated because there is a potential for the wrong patient information to be displayed in the viewer or PowerJacket. Additionally, the software may return incorrect maximum standard uptake values (SUV) for PET and CT studies when used with Siemens modalities.
Medical facilities that have installed these specific versions of the software should contact Fujifilm Medical Systems U.S.A., Inc. for further instructions on how to resolve the issue.
The recalled product
- Product
- Synapse PACS Software Versions 5.1 and higher
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Category
- Medical Device — Software
- Affected units
- 235
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Software Versions 5.1
- 5.2
- 5.3
- 5.4
- 5.5
- and 5.7.
Distribution
Distributed nationwide across the United States.
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