Fujifilm Medical Systems U.S.A., Inc.: Medical Device Recall in 2021 - (Recall #: Z-0878-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Synapse PACS Software Versions 5.1 and higher

Product Classification:

Class II

Date Initiated: September 11, 2020

Date Posted: January 27, 2021

Recall Number: Z-0878-2021

Event ID: 86532

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.

Status: Ongoing

Product Quantity: 235

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.

Voluntary or Mandated:

Voluntary: Firm initiated