Z-1172-2024Class II

Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical...

Name: Z-1172-2024 Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical...
Creator: FUJIFILM Healthcare Americas Corporation
Published: 2024-01-03
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2024-01-03 / Open, Classified / root cause: software

FDA source

FUJIFILM Healthcare Americas Corporation began a recall of Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images on 2024-01-03. FDA classified it as Class II and gives the reason as "The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1172-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-03
Posted: 2024-02-21
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a patient, resulting in long-term health consequences or serious deterioration of health.
Root cause tag: software
FDA root cause: Software design
Action: On January 3, 2024, the firm notified customers via URGENT MEDICAL DEVICE CORRECTION letters. Fujifilm will offer to correct the formula that calculates the LV Mass (2D Bullet) in the Synapse database. Until the update is scheduled and completed, customers may continue to safely use the Pediatric Workflow modules listed in the notice as long as the LV Mass (2D Bullet) equation is not the main factor for a diagnosis. Customers should coordinate with the Fujifilm service engineer to schedule the correction of their device when contacted. Please contact Fujifilm's field action coordinator, Kotei Aoki, via phone at 765-246-2931 or email at [email protected], if you have any further questions regarding this field action.
Quantity in commerce: 8
Distribution: US domestic distribution nationwide. International distribution to Israel.
Product codes and lots: UDI-DI 00854904006015 Software versions 6.2.1, 6.2.0, 6.1.1, 6.1.0, 6.0.1, and 6.0.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1172-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1171-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-21
Z-1172-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-28	2024-02-21

Product code LLZ

K151859Class IISynapse CardiovascularFujifilm Medical Systems U.S.A, Inc. / cleared 2015-08-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)