Fujifilm Synapse PACS Software Recall for Image Display Failure
Fujifilm Medical Systems is recalling 27 units of Synapse PACS software versions 4.4.000 through 4.4.020 because the software fails to display medical images, showing an error message instead.
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 is classified as FDA Class II and involves a medical device software defect that prevents the display of medical images, which is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling 27 units of Fujifilm Synapse PACS software, specifically versions 4.4.000, 4.4.001, 4.4.004, 4.4.010, and 4.4.020. The affected software is intended to serve as the primary user interface for processing and presenting medical images on displays. The recall is due to a defect where the software cannot display image files, DICOM SR files, and/or Annotation files, resulting in an "Image Not Loaded" message being displayed to the user.
The affected units were distributed in the United States to the states of California, Florida, Kansas, Nebraska, New York, and Pennsylvania. The recall is classified as Class II by the U.S. Food and Drug Administration. No specific instructions for consumers or healthcare providers are provided in the source text beyond the identification of the defect.
The recalled product
- Product
- Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.004, Fujifilm Synapse PACS software version 4.4.010 and Fujifilm Synapse PACS software version 4.4.020 FUJIFILM Synapse Workstation…
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Category
- Medical Device — Software
- Affected units
- 27
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 (5)
- Software version: 4.4.000
- 4.4.001
- 4.4.004
- 4.4.010
- 4.4.020
Distribution
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