Fujifilm Synapse PACS Recalled for Potential Wrong Patient Information Display
Fujifilm Medical Systems is recalling Synapse PACS software because it may display incorrect patient information in the viewer or PowerJacket.
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 information may be displayed, posing a risk of harm to patients through misdiagnosis or treatment errors, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling 839 units of the Synapse PACS Radiological Image Processing System. The recall involves software versions 5.1 through 5.7.200. The product is intended for use as a web-based application on a PC networked with FUJIFILM Synapse PACS Software (Server).
The recall is being issued because the wrong patient information may be displayed in the viewer or PowerJacket. This defect could lead to the review of incorrect medical images or patient data.
The affected systems were distributed worldwide, including nationwide distribution in the United States and in numerous other countries. Users of the affected software should contact Fujifilm Medical Systems U.S.A., Inc. for further instructions on how to address the issue.
The recalled product
- Product
- Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server).
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Category
- Medical Device — Software
- Affected units
- 839
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 (1)
- Software version: 5.1 to 5.7.200
Distribution
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