Recall Z-1171-2024 ยท LLZ System, Image Processing, Radiological
FUJIFILM Healthcare Americas Corporation
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.
| Date | Feb 21, 2024 (initiated Jan 3, 2024) |
| Status | Open, Classified |
| Reason | 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 | 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, Kot |
| Quantity | 13 |
| Distribution | US domestic distribution nationwide. International distribution to Israel. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190232 | Synapse PACS Fujifilm Corporation, Mar 26, 2019 |