Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
FDA device recall Z-1172-2024 · posted 2024-02-21 · Open, Classified
Recall details
- Recalling firm
- FUJIFILM Healthcare Americas Corporation
- 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.
- Action taken
- 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 kotei.aoki@fujifilm.com, if you have any further questions regarding this field action.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- LLZ
- Quantity affected
- 8
- Distribution
- US domestic distribution nationwide. International distribution to Israel.
- Date initiated
- 2024-01-03
- Date posted
- 2024-02-21
- Location
- Lexington, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Synapse Cardiovascular (K151859) | Fujifilm Medical Systems U.S.A, Inc. | 2015-08-12 |