The Recall Desk
HighFDA (Devices)·Z-1775-2021·Announced 2021-06-09

Synapse Cardiovascular software may incorrectly reuse patient database identifiers

Fujifilm's Synapse Cardiovascular software versions 6.0.4 to 6.2.1 contain a defect in the Advanced Reporting function where previously assigned patient database identification numbers can be reused for new patients when specific patient merge operations are executed.

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: This is an FDA Class II medical device recall involving a software defect with risk-of-harm potential in a medical imaging system where patient identification errors could occur. No illnesses or injuries have been reported, meeting the criterion for Score 3: risk-of-harm products where injury has not yet been reported.

Plain-English summary

Fujifilm Medical Systems U.S.A., Inc. is recalling Synapse Cardiovascular (Synapse CV) imaging management software, versions 6.0.4 through 6.2.1. A defect in the Advanced Reporting function allows previously used patient database identification numbers to be incorrectly reused for new patients. This occurs when patient merge operations are performed in a specific sequence, causing the software to fail to properly increment the patient ID counter.

The affected software has been distributed nationwide in the United States and internationally to Canada, Bermuda, Israel, and Hadassah Medical Center. Distribution includes 44 units in the US and 4 units internationally.

This defect could result in patient records being incorrectly associated with imaging studies or reports, potentially affecting the accuracy of patient-specific clinical information. No illnesses or patient harm from this issue have been reported to date.

The recalled product

Product
Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
Manufacturer
Fujifilm Medical Systems U.S.A., Inc.
Category
Medical Device — Medical Imaging / Cardiovascular
Hazard
  • patient-id-reuse
  • patient-data-integrity

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 (1)

  • Software Versions: 6.0 to 6.2.1

Distribution

Distributed nationwide across the United States.

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