Fujifilm Synapse PACS Software Recalled for Potential Image Data Errors
Fujifilm Medical Systems is recalling Synapse PACS software versions 4.0 through 4.3 because patient image data may be incorrect.
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 where incorrect patient image data could lead to misdiagnosis or treatment errors, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling 251 units of Fujifilm Synapse PACS software, versions 4.0.xxx, 4.1.xxx, 4.2.xxx, and 4.3.xxx. This medical imaging and information management system is used for archiving and distributing image information from various modalities.
The recall was initiated because image data for a patient's image may not be correct. The affected software was distributed nationwide in the United States.
Healthcare facilities using this software should contact Fujifilm Medical Systems U.S.A., Inc. for instructions on how to resolve the issue and ensure the accuracy of patient image data.
The recalled product
- Product
- Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 251
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 (4)
- Software versions: 4.0.xxx
- 4.1.xxx
- version 4.2.xxx
- version 4.3.xxx
Distribution
Distributed nationwide across the United States.
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