FUJIFILM Healthcare Americas Corporation has recalled 104 units of its Synapse PACS Software Version 7.4.x because it may display the incorrect age for patients under three months old. The software defect specifically affects the VX viewer, where a computation error can lead to the wrong age being shown to clinicians. While no incidents or injuries have been reported, clinicians should be aware that the displayed patient age for infants may be inaccurate.
If a healthcare provider relies on the incorrect patient age displayed by the software when reviewing images, it could lead to incorrect diagnostic interpretations or medical decisions for infants under three months of age. No incidents or injuries have been reported in relation to this software issue.
Units Affected: 104 units (69 US, 35 OUS).
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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