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Synapse CV 6. with AR recallZ-1172-2024 · FUJIFILM Healthcare Americas Corporation · initiated Jan 3, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from FUJIFILM Healthcare Americas Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software design

What the company is doing

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.

Recall details

Recall number
Z-1172-2024
Status
Open, Classified
Initiated by the company
Jan 3, 2024
Posted by the FDA
Feb 21, 2024
Recalling firm
FUJIFILM Healthcare Americas Corporation
Quantity
8
Product code
LLZ
FDA submissions
K151859
Distribution
US domestic distribution nationwide. International distribution to Israel.

Product description

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

Code information (models, lots, serial numbers)

UDI-DI 00854904006015 Software versions 6.2.1, 6.2.0, 6.1.1, 6.1.0, 6.0.1, and 6.0.0

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 93855).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page