Skip to content
Recall Observatory FDA recall evidence

Device product

Synapse PACS Software Versions 5.1 and higher

Z-0878-2021

September 11, 2020

Class II

Product summary

Firm
Fujifilm Medical Systems U.S.A., Inc.
Event
Event 86532
Status
Ongoing
Classification
Class II
Quantity
235
Official record key
device-enforcement:Z-0878-2021

Official wording

Reason: There 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.

Code information: Software Versions 5.1, 5.2, 5.3, 5.4, 5.5, and 5.7.

Distribution pattern: Software was distributed to medical facilities nationwide throughout the U.S.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There 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.