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Fujifilm Medical Systems U.S.A., Inc. Recall 86532

Description: Synapse PACS Software Versions 5.1 and higher

Fujifilm Medical Systems U.S.A., Inc. Recall 86532 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0878-2021
Event ID86532
Event DescriptionSynapse PACS Software Versions 5.1 and higher
Product TypeDevices
DistributionSoftware was distributed to medical facilities nationwide throughout the U.S.
Quantity235
Recall ReasonThere is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modality.
Device Classification20210127
Device Code InfoSoftware Versions 5.1, 5.2, 5.3, 5.4, 5.5, and 5.7.
Center Classification Date20210116
Recall Initiation Date20200911
Recalling FirmFujifilm Medical Systems U.S.A., Inc.
Initial Notification Letter
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