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FUJIFILM Healthcare Americas Corporation Recall 94090

Description: Synapse PACS - Version 7.1.000

FUJIFILM Healthcare Americas Corporation Recall 94090 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1268-2024
Event ID94090
Event DescriptionSynapse PACS - Version 7.1.000
Product TypeDevices
DistributionWorldwide distribution - US Nationwide, including Puerto Rico and the countries of Australia, Belgium, Brazil, Canada, Colombia, Ecuador, France, Germany, India, Italy, Mexico, Namibia, Netherlands, Portugal, Qatar, Spain, Thailand, Turkey, UAE, United Kingdom.
Quantity22 units (22 OUS)
Recall ReasonMeasurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
Device Classification20240313
Device Code InfoSoftware Version: 7.1.000; UDI: (01)854904006008(10)0701000
Center Classification Date20240307
Recall Initiation Date20240110
Recalling FirmFUJIFILM Healthcare Americas Corporation
Initial Notification Letter
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