The Recall Desk
HighFDA (Devices)·Z-0073-2017·Announced 2016-10-19

Fujifilm Synapse PACS Software Recalled for Potential Image Data Errors

Fujifilm Medical Systems is recalling Synapse PACS software versions 4.0 through 4.3 because patient image data may be incorrect.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where incorrect patient image data could lead to misdiagnosis or treatment errors, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Fujifilm Medical Systems U.S.A., Inc. is recalling 251 units of Fujifilm Synapse PACS software, versions 4.0.xxx, 4.1.xxx, 4.2.xxx, and 4.3.xxx. This medical imaging and information management system is used for archiving and distributing image information from various modalities.

The recall was initiated because image data for a patient's image may not be correct. The affected software was distributed nationwide in the United States.

Healthcare facilities using this software should contact Fujifilm Medical Systems U.S.A., Inc. for instructions on how to resolve the issue and ensure the accuracy of patient image data.

The recalled product

Product
Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities
Manufacturer
Fujifilm Medical Systems U.S.A., Inc.
Category
Medical Device — Software
Hazard
Affected units
251

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Software versions: 4.0.xxx
  • 4.1.xxx
  • version 4.2.xxx
  • version 4.3.xxx

Distribution

Distributed nationwide across the United States.

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Same hazard · data integrity

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