Synapse CardioVascular Synapse Cardiology PACS Software LicenseRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00854904006015), received between Jan 13, 2021 and Jan 13, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Computer Software Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K151859); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jan 3, 2024Class IIOpen, Classified

   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.

   Z-1172-2024 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2021Computer Software Problem; Computer Software Problem

  ON DECEMBER 02, 2020 FUJIFILM MEDICAL SYSTEMS U.S.A., INC. (FMSU) SERVICE DEPARTMENT RECEIVED A CUSTOMER INQUIRY FOR ASSISTANCE WITH SYNAPSE CARDIOVASCULAR. STUDY WAS SENT IN FOR A NEW PATIENT WITH THE CORRECT MRN. INCORRECT MRN IS SHOWING IN CV CLIENT. ON DECEMBER 16, 2020, A RISK ASSESSMENT WAS PERFORMED TO INVESTIGATE THE RISK TO PATIENT SAFETY. THERE WAS NO PATIENT IMPACT, SERIOUS INJURY, OR DEATH ASSOCIATED WITH THIS EVENT. THE ISSUE IS CONSIDERED HIGHLY DETECTABLE BY A HEALTHCARE PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11159001 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151859. One submission often covers many models, so check the product and lot details in each record.

• Z-1775-2021 · Apr 30, 2021 · Terminated
  Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system