FUJIFILM Healthcare Americas Corporation: Cardiology PACS and CV Software Recalled for Heart Measurement Errors

Agency Publication Date: February 21, 2024

Summary

FUJIFILM Healthcare Americas Corporation has recalled 21 units of its Synapse Cardiology PACS (versions 7.0 through 7.3.0) and Synapse CV 6 with AR medical imaging software. The software contains a defect where the '2D Bullet' equation used to calculate the mass of a patient's left ventricle may produce incorrect results. This recall affects specific software versions distributed to healthcare facilities nationwide and in Israel between January and February 2024. Because clinical diagnoses often rely on these measurements, an error could lead to an incorrect treatment plan or misdiagnosis. Consumers and healthcare providers should contact the manufacturer for further guidance.

Risk

The software's calculation error can result in an incorrect measurement of the left ventricle's mass. If a doctor uses this inaccurate data as a primary factor for a diagnosis, it creates a high risk of misdiagnosis or the creation of an inappropriate treatment plan, which could lead to serious long-term health consequences or a life-threatening deterioration of a patient's condition.

What You Should Do

Identify if your facility is using Synapse Cardiology PACS versions 7.3.000, 7.2.200, 7.2.100, 7.2.000, 7.1.000, or 7.0.000 (UDI-DI 854904006008).
Identify if your facility is using Synapse CV 6 with AR versions 6.2.1, 6.2.0, 6.1.1, 6.1.0, 6.0.1, or 6.0.0 (UDI-DI 00854904006015).
Healthcare professionals should immediately stop using the LV Mass (2D Bullet) equation within the affected software versions for clinical diagnosis until a patch or update is provided.
Review past patient records where this specific calculation was used to determine if a re-evaluation of the diagnosis or treatment plan is necessary.
Contact FUJIFILM Healthcare Americas Corporation at their headquarters in Lexington, MA, or through your authorized service representative for information regarding software updates and corrective actions.
Patients who have recently undergone cardiac imaging using these systems should contact their healthcare provider to confirm if their results were affected by this calculation variance.
For additional questions, contact the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

Other Action

Firm initiated notification by letter.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential software updates or workarounds.

Affected Products

Product: Synapse Cardiology PACS (Versions 7.0, 7.1, 7.2, 7.3.0)

Model / REF:

7.3.000

7.2.200

7.2.100

7.2.000

7.1.000

7.0.000

Lot Numbers:

UDI-DI 854904006008

Product: Synapse CV 6. with AR

Model / REF:

6.2.1

6.2.0

6.1.1

6.1.0

6.0.1

6.0.0

Lot Numbers:

UDI-DI 00854904006015

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93855

Status: Active

Manufacturer: FUJIFILM Healthcare Americas Corporation

Sold By: FUJIFILM Healthcare Americas Corporation

Manufactured In: United States

Units Affected: 2 products (13; 8)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Identify if your facility is using Synapse Cardiology PACS versions 7.3.000, 7.2.200, 7.2.100, 7.2.000, 7.1.000, or 7.0.000 (UDI-DI 854904006008).

Identify if your facility is using Synapse CV 6 with AR versions 6.2.1, 6.2.0, 6.1.1, 6.1.0, 6.0.1, or 6.0.0 (UDI-DI 00854904006015).

Healthcare professionals should immediately stop using the LV Mass (2D Bullet) equation within the affected software versions for clinical diagnosis until a patch or update is provided.

Review past patient records where this specific calculation was used to determine if a re-evaluation of the diagnosis or treatment plan is necessary.

Contact FUJIFILM Healthcare Americas Corporation at their headquarters in Lexington, MA, or through your authorized service representative for information regarding software updates and corrective actions.

Patients who have recently undergone cardiac imaging using these systems should contact their healthcare provider to confirm if their results were affected by this calculation variance.

For additional questions, contact the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA).