Fujifilm Synapse PACS Software Recalled for Incorrect Orientation Markers
Fujifilm is recalling Synapse PACS Software versions 5.5.x and 5.7.x because incorrect orientation markers and slice locations may lead to misdiagnosis.
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 risk-of-harm product (medical software) where the hazard is misdiagnosis, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling 135 units of Fujifilm Synapse PACS Software, versions 5.5.x and 5.7.x. The software is intended to serve as an interface to the FUJIFILM Synapse PACS Software (Server). The recall covers units distributed nationwide.
The recall was initiated because Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly on the 3D TOMO slider bar. Additionally, the slice location of the image and/or the slice direction could be incorrect. These errors may result in misdiagnosis.
Healthcare facilities and users of the affected software should contact Fujifilm Medical Systems U.S.A., Inc. for instructions on how to resolve the issue. The source text does not specify a specific action for consumers, as this is a medical device software recall.
The recalled product
- Product
- Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Category
- Medical Device — Software
- Affected units
- 135
Distribution
Distributed nationwide across the United States.
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