The Recall Desk
HighFDA (Devices)·Z-1171-2024·Announced 2024-02-28

Cardiology imaging software may calculate heart chamber size incorrectly

Synapse Cardiology PACS software versions 7.0–7.3.0 may calculate left ventricle mass incorrectly, potentially leading to misdiagnosis or wrong treatment plans. Thirteen units have been distributed in the US and Israel.

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 recall with theoretical risk of serious patient harm (misdiagnosis, incorrect treatment, long-term health consequences) but no reported illnesses, injuries, or deaths. Per the severity rubric, risk-of-harm products where injury has not yet been reported score at most 3 (High).

Plain-English summary

Synapse Cardiology PACS V7.3.0, V7.2, V7.1, and V7.0 is a web-based software application used as the primary interface for processing cardiac medical images. The software is manufactured by FUJIFILM Healthcare Americas Corporation and has been distributed nationwide in the United States and to Israel.

A calculation error in the LV Mass (2D Bullet) equation within the software may produce incorrect measurements of the left ventricle mass. If these measurements are used as a main diagnostic factor, the error could lead to patient misdiagnosis or an incorrect treatment plan, potentially resulting in long-term health consequences or serious deterioration of a patient's health.

This recall affects 13 units of the software (UDI-DI 854904006008, software versions 7.3.000, 7.2.200, 7.2.100, 7.2.000, 7.1.000, 7.0.000). Healthcare facilities currently using these versions should contact FUJIFILM Healthcare Americas Corporation for updated software or further guidance.

The recalled product

Product
Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the processing of medical images.
Manufacturer
FUJIFILM Healthcare Americas Corporation
Category
Medical Device — Diagnostic Software
Hazard
  • calculation-error
  • misdiagnosis-risk
  • treatment-error-risk

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 (6)

  • UDI-DI 854904006008 Software versions 7.3.000
  • 7.2.200
  • 7.2.100
  • 7.2.000
  • 7.1.000
  • 7.0.000

Distribution

Distributed nationwide across the United States.

Related recalls

Same category