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Open, Classified

Synapse PACS Software Versions 5.1 and higher

FDA Recall Z-0878-2021 · Posted None

Recalling FirmFujifilm Medical Systems U.S.A., Inc.
Recall StatusOpen, Classified
Product CodeLLZ
Date Initiated2020-09-11
Product Quantity235

Reason for Recall

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.

Firm Action

Letter was sent to all affected customers on 09/11/2020 stating the following: There have been no reported patient injuries associated with these issues. In an effort to ensure the highest level of customer satisfaction, FUJIFILM will offer an upgrade to Synapse PACS 5.7.200US to resolve these issues. Until your upgrade is scheduled and completed, you can continue to safely use Synapse PACS by following these additional instructions: 1. When selecting a patient off the PowerJacket or work list, please ensure that the patient information displayed in the viewer matches the desired patient and matches the PowerJacket. 2. If using a Siemens Modality, Max SUVs should not be used when rendering a clinical decision until the issue is corrected. Please complete and return the Field Action Verification Form attached on page 3 of this communication. Providing the response with the information requested is essential for ensuring appropriate action is taken.

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc. · 2016-02-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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