Synapse Radiology PACS Synapse Radiology PACS Software LicenseRecalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00854904006008), received between May 15, 2020 and Jan 30, 2025 — classified as 1 injury, 37 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (35 reports).

9 FDA recall records name this device's identifier, 9 still open.

5 other recalls cover devices cleared under the same FDA submission (K160108, K190232, K243647, K261713); 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. Jul 22, 2026Class IIOpen, Classified

   Software issue may cause the ruler measurement to be inaccurate.

   Z-3030-2026 · Root cause: Software design · Recall details · FDA record ↗

2. Feb 11, 2025Class IIOpen, Classified

   The incorrect computed patient age is showing in VX for patients less than 3 months old.

   Z-1407-2025 · Root cause: Software change control · Recall details · FDA record ↗

3. Jan 10, 2024Class IIOpen, Classified

   Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.

   Z-1268-2024 · Root cause: Software design · Recall details · FDA record ↗

4. Jan 10, 2024Class IIOpen, Classified

   Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.

   Z-1273-2024 · Root cause: Software design · Recall details · FDA record ↗

5. Jan 10, 2024Class IIOpen, Classified

   Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.

   Z-1271-2024 · Root cause: Software design · Recall details · FDA record ↗

6. Jan 10, 2024Class IIOpen, Classified

   Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.

   Z-1272-2024 · Root cause: Software design · Recall details · FDA record ↗

7. Jan 10, 2024Class IIOpen, Classified

   Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.

   Z-1269-2024 · Root cause: Software design · Recall details · FDA record ↗

8. Jan 10, 2024Class IIOpen, Classified

   Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.

   Z-1270-2024 · Root cause: Software design · Recall details · FDA record ↗

9. 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-1171-2024 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2025Incorrect Measurement; Device Displays Incorrect Message; Incorrect Measurement; Device Displays Incorrect Message

  ON (B)(6) 2025, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF A PRODUCT PROBLEM INVOLVING WITH SYNAPSE SOFTWARE VERSION 7.4.2. IT WAS REPORTED THAT THE PATIENT'S AGE IS SHOWING AS ONE MONTH EARLIER THAN IT SHOULD BE ON PEDIATRIC STUDIES IN THE VX VIEWER. SCROLLING THROUGH THE IMAGES SOMETIMES FIXES THE ISSUE. THIS HAPPENS ON MULTIPLE WORKSTATIONS, BOTH IN THE PRODUCTION AND TEST ENVIRONMENT. THE IMAGE SENDER IS MISSING IN SWAT'S OVERLAY AND USING THE DEFAULT TEXT OVERLAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21273940 ↗
• MalfunctionJan 30, 2025Incorrect Measurement; Device Displays Incorrect Message; Incorrect Measurement; Device Displays Incorrect Message

  ON 17-JAN-2025, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF A PRODUCT PROBLEM INVOLVING WITH SYNAPSE SOFTWARE VERSION 7.4.010. THE PATIENT'S AGE IS SHOWING INCORRECTLY IN THE SYNAPSE VX VIEWER, BUT IT APPEARS FINE IN ZERO VIEWER. FOR EXAMPLE, A FETAL PATIENT IS SHOWING AS 5 DAYS IN VX, BUT IT SHOULD BE 26 DAYS. HOWEVER, IF THE PATIENT'S DATE OF BIRTH IS IN THE CURRENT MONTH (B)(6) 2025), VX DISPLAYS THE CORRECT AGE. THIS SUGGESTS THERE MAY BE AN ISSUE WITH HOW VX IS CALCULATING AGES FOR PATIENTS WITH DATES OF BIRTH OUTSIDE THE CURRENT MONTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21273610 ↗
• MalfunctionDec 21, 2023Computer Software Problem; Computer Software Problem

  ON (B)(6), 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF A PRODUCT PROBLEM INVOLVING SYNAPSE SOFTWARE. IT WAS REPORTED THAT THE SITE UPGRADED FROM V5.7 TO V. 7.3 LAST MONTH. IN V5.7, WHEN IMAGES WERE ANNOTATED IN VRAD AND SENT TO SYNAPSE, THE IMAGE SIZE (MG ONLY) WAS MAINTAINED SINCE THE UPGRADE TO V7.3.002. THE IMAGES INITIALLY DISPLAYED THE EXPECTED SIZE BUT IF THEY SCROLL THROUGH THE IMAGES, THE SIZE SHRINKS TO VERY SMALL. THE SITE HAS TRIED TO ADJUST THE DIFFERENT ZOOM FACTORS AND USING JUST A SYNAPSE DEFAULT READING PROTOCOL WITH NO LUCK. NO ADDITIONAL INFORMATION PROVIDED..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18377215 ↗
• MalfunctionAug 23, 2023Computer Software Problem; Computer Software Problem

  ON (B)(6) 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF A PRODUCT PROBLEM INVOLVING SYNAPSE PACS V7.3. IT WAS REPORTED THAT THERE IS AN INCORRECT EQUATION FOR LV MASS (2D BULLET) CALCULATION. THE FORMULA THAT EQUATES THE MASS OF THE LEFT VENTRICLE IS INCORRECTLY CALCULATING THE LV WALL THICKNESS CAUSING THE DIFFERENCE TO VARY DEPENDING ON THE AMOUNT OF THICKNESS THAT EXISTS IN THE VENTRICLE. THICKER LV WALLS WILL CAUSE A LARGER DIFFERENCE IN THE RESULTS. THERE WAS NO PATIENT INVOLVEMENT REPORTED. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17607600 ↗
• MalfunctionApr 21, 2023Computer Software Problem; Computer Software Problem

  ON (B)(6) 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF AN EVENT INVOLVING SYNAPSE PACS V7.1. IT WAS REPORTED THAT A MEASUREMENT ISSUE OCCURRED WHILE MEASURING A PEDIATRIC CATHETERIZATION IMAGE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16791846 ↗
• MalfunctionOct 20, 2022Computer Software Problem; Computer Software Problem

  ON OCTOBER 6, 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF AN EVENT INVOLVING SYNAPSE PACS V5.7.212. IT WAS REPORTED THAT THE USER EXPERIENCED A PATIENT MISMATCH ISSUE BETWEEN POWERJACKET AND THE VIEWER. THERE WAS NO PATIENT INVOLVEMENT REPORTED. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15638949 ↗
• MalfunctionSep 26, 2022Computer Software Problem; Computer Software Problem

  ON (B)(6) 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF AN EVENT INVOLVING SYNAPSE PACS V7.1 THAT OCCURRED ON (B)(6) 2022. IT WAS REPORTED THAT THE USER EXPERIENCED A PATIENT MISMATCH ISSUE BETWEEN POWERJACKET AND THE VIEWER. THERE WAS NO PATIENT INVOLVEMENT REPORTED. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15486165 ↗
• MalfunctionSep 26, 2022Computer Software Problem; Computer Software Problem

  ON SEPTEMBER 2, 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF AN EVENT INVOLVING SYNAPSE PACS V5.7.245. IT WAS REPORTED THAT THE USER EXPERIENCED A PATIENT MISMATCH ISSUE BETWEEN POWERJACKET AND THE VIEWER. THERE WAS NO PATIENT INVOLVEMENT REPORTED. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15486063 ↗
• MalfunctionJan 20, 2022Computer Software Problem; Computer Software Problem

  ON 01/04/2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A CUSTOMER INQUIRY FOR ASSISTANCE WITH SYNAPSE PACS. THERE WAS A ISSUE NOTED IS AS FOLLOWS: IT WAS REPORTED THAT THE SYNAPSE PACS 5.7.230 PATIENT MISMATCH ISSUE OCCURRED WITH DESKTOP AGENT ON LRMC RADIOLOGY DIAGNOSTIC WORKSTATION LRMCMD112177 (COL (B)(6)). THERE WAS NO PATIENT IMPACT, SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT. THE ISSUE IS CONSIDERED HIGHLY DETECTABLE BY A HEALTHCARE PROFESSIONAL; HOWEVER THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13307166 ↗
• MalfunctionJan 19, 2022Computer Software Problem; Computer Software Problem

  ON 04/14/2021, FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED A CUSTOMER INQUIRY FOR ASSISTANCE WITH SYNAPSE PACS. THERE WAS A ISSUE NOTED IS AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT HISTORY DID NOT REFRESH AFTER STUDY CHANGE. THE PREVIOUS PATIENT INFORMATION IS DISPLAYED. THERE WAS NO PATIENT IMPACT, SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT. THE ISSUE IS CONSIDERED HIGHLY DETECTABLE BY A HEALTHCARE PROFESSIONAL; HOWEVER THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13291402 ↗
• MalfunctionJul 7, 2021Computer Software Problem; Computer Software Problem

  ON (B)(6) 2019, FUJIFILM MEDICAL SYSTEMS U.S.A., INC. (FMSU) RECEIVED A CUSTOMER INQUIRY FOR ASSISTANCE WITH SYNAPSE PACS. THERE WAS AN ISSUE NOTED THAT IS DESCRIBED BELOW: WHEN THE USER ATTEMPTS TO OPEN A REPORT FOR PATIENT A, STUDY DETAILS FOR PATIENT B ARE DISPLAYED. THIS ERROR IS EASILY IDENTIFIED SINCE NAME DISPLAYED DOES NOT MATCH. THERE WAS NO PATIENT IMPACT, SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT. THE ISSUE IS CONSIDERED HIGHLY DETECTABLE BY A HEALTHCARE PROFESSIONAL; HOWEVER THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129429 ↗
• MalfunctionJul 7, 2021Computer Software Problem; Computer Software Problem

  ON (B)(6) 2020, FUJIFILM MEDICAL SYSTEMS U.S.A., INC. (FMSU) RECEIVED A CUSTOMER INQUIRY FOR ASSISTANCE WITH SYNAPSE PACS. THERE WAS A ISSUE NOTED IS AS FOLLOWS: WHEN THE USER ATTEMPTS TO OPEN A STUDY FOR PATIENT A, STUDY DETAILS FOR PATIENT B IS DISPLAYED. THERE WAS NO PATIENT IMPACT, SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT. THE ISSUE IS CONSIDERED HIGHLY DETECTABLE BY A HEALTHCARE PROFESSIONAL; HOWEVER THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129350 ↗
• MalfunctionJul 7, 2021Computer Software Problem; Computer Software Problem

  ON 11/20/2019, FUJIFILM MEDICAL SYSTEMS U.S.A., INC. (FMSU) RECEIVED A CUSTOMER INQUIRY FOR ASSISTANCE WITH SYNAPSE PACS. THERE WAS A ISSUE NOTED IS AS FOLLOWS: WHEN THE USER ATTEMPTS TO OPEN A STUDY FOR PATIENT A, STUDY DETAILS FOR PREVIOUSLY VIEWED PATIENT'S NAME IS DISPLAYED. 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 12129328 ↗
• MalfunctionJul 7, 2021Computer Software Problem; Computer Software Problem

  ON 11/13/2019, FUJIFILM MEDICAL SYSTEMS U.S.A., INC. (FMSU) RECEIVED A CUSTOMER INQUIRY FOR ASSISTANCE WITH SYNAPSE PACS. THERE WAS A ISSUE NOTED WITH THE THIN CLIENT AS FOLLOWS: WHEN THE USER ATTEMPTS TO OPEN A STUDY FOR PATIENT A, STUDY DETAILS FOR PATIENT B ARE DISPLAYED. THERE WAS NO PATIENT IMPACT, SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT. THE ISSUE IS CONSIDERED HIGHLY DETECTABLE BY A HEALTHCARE PROFESSIONAL; HOWEVER THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129303 ↗
• MalfunctionJul 7, 2021Computer Software Problem; Computer Software Problem

  ON (B)(6) 2019, FUJIFILM MEDICAL SYSTEMS U.S.A., INC. (FMSU) RECEIVED A CUSTOMER INQUIRY FOR ASSISTANCE WITH SYNAPSE PACS. THERE WAS AN ISSUE NOTED THAT IS DESCRIBED BELOW: WHEN THE USER TRIED TO PULL A REPORT FOR PATIENT A, NAME AND REPORT FOR PATIENT B IS DISPLAYED. USER ATTEMPTS AGAIN AND ERROR IS CORRECTED. THERE WAS NO PATIENT IMPACT, SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT. THE ISSUE IS CONSIDERED HIGHLY DETECTABLE BY A HEALTHCARE PROFESSIONAL; HOWEVER THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129271 ↗
• MalfunctionJul 7, 2021Computer Software Problem; Computer Software Problem

  ON 04/16/2020, FUJIFILM MEDICAL SYSTEMS U.S.A., INC. (FMSU) RECEIVED A CUSTOMER INQUIRY FOR ASSISTANCE WITH SYNAPSE PACS. THERE WAS A ISSUE NOTED IS AS FOLLOWS: WHEN THE USER ATTEMPTS TO OPEN A STUDY FOR PATIENT A, INCORRECT PATIENT DATA AND IMAGES ARE DISPLAYED. 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 12129160 ↗
• MalfunctionJul 7, 2021Computer Software Problem; Computer Software Problem

  ON (B)(6) 2019, FUJIFILM MEDICAL SYSTEMS U.S.A., INC. (FMSU) RECEIVED A CUSTOMER INQUIRY FOR ASSISTANCE WITH SYNAPSE PACS. THERE WAS AN ISSUE NOTED THAT IS DESCRIBED BELOW: WHEN THE USER TRIED TO PULL A REPORT FOR AN EXAM, RESULTS FROM UNRELATED EXAM IS BEING DISPLAYED. ONCE THE USER LOGS OUT AND LOGS BACK IN THE ERROR IS CORRECTED. THERE WAS NO PATIENT IMPACT, SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT. THE ISSUE IS CONSIDERED HIGHLY DETECTABLE BY A HEALTHCARE PROFESSIONAL; HOWEVER THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129123 ↗
• MalfunctionJul 7, 2021Computer Software Problem; Computer Software Problem

  ON (B)(6) 2019, FUJIFILM MEDICAL SYSTEMS U.S.A., INC. (FMSU) RECEIVED A CUSTOMER INQUIRY FOR ASSISTANCE WITH SYNAPSE PACS. THERE WAS AN ISSUE NOTED THAT IS DESCRIBED BELOW: WHEN THE USER TRIED TO PULL A REPORT FOR AN EXAM, RESULTS FROM UNRELATED EXAM IS BEING DISPLAYED. ONCE THE USER LOGS OUT AND LOGS BACK IN THE ERROR IS CORRECTED. THERE WAS NO PATIENT IMPACT, SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT. THE ISSUE IS CONSIDERED HIGHLY DETECTABLE BY A HEALTHCARE PROFESSIONAL; HOWEVER THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12128548 ↗
• MalfunctionJul 7, 2021Computer Software Problem; Computer Software Problem

  ON 09/11/2019, FUJIFILM MEDICAL SYSTEMS U.S.A., INC. (FMSU) RECEIVED A CUSTOMER INQUIRY FOR ASSISTANCE WITH SYNAPSE PACS. THERE WAS AN ISSUE NOTED THAT IS DESCRIBED BELOW: WHEN THE USER ATTEMPTS TO OPEN A STUDY FOR PATIENT A, STUDY DETAILS FOR PATIENT B ARE DISPLAYED. 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 12127987 ↗
• MalfunctionJul 7, 2021Computer Software Problem; Computer Software Problem

  ON (B)(6) 2019, FUJIFILM MEDICAL SYSTEMS U.S.A., INC. (FMSU) RECEIVED A CUSTOMER INQUIRY FOR ASSISTANCE WITH SYNAPSE PACS. THERE WAS AN ISSUE NOTED THAT IS DESCRIBED BELOW: WHEN THE USER TRIED TO PULL A REPORT FOR PATIENT A, NAME OF PATIENT B IS DISPLAYED. THERE WAS NO PATIENT IMPACT, SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT. THE ISSUE IS CONSIDERED HIGHLY DETECTABLE BY A HEALTHCARE PROFESSIONAL; HOWEVER THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12127862 ↗
• MalfunctionJul 6, 2021Computer Software Problem; Computer Software Problem

  ON (B)(6) 2019, FUJIFILM MEDICAL SYSTEMS U.S.A., INC. (FMSU) RECEIVED A CUSTOMER INQUIRY FOR ASSISTANCE WITH SYNAPSE PACS. THERE WERE ISSUES NOTED WITH THE THIN CLIENT AS FOLLOWS: WHEN THE USER ATTEMPTS TO OPEN A STUDY FOR PATIENT A, STUDY DETAILS FOR PATIENT B ARE DISPLAYED. WHILE USING TITLE VIEW, UPON HOVERING THE MOUSE ON NOTE, IT DISPLAYS A NOTE FOR A DIFFERENT PATIENT. THERE WAS NO PATIENT IMPACT, SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT. THE ISSUE IS CONSIDERED HIGHLY DETECTABLE BY A HEALTHCARE PROFESSIONAL; HOWEVER THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12121171 ↗
• MalfunctionApr 14, 2021Computer Software Problem; Computer Software Problem

  ON (B)(6) 2021 FUJIFILM MEDICAL SYSTEMS USA, INC. (FMSU) WAS MADE AWARE OF AN INCIDENT WITH SYNAPSE PACS. A URL CALL FROM RIS RESULTS IN A PATIENT/STUDY MISMATCH. ON (B)(6) 2021 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; HOWEVER THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11665957 ↗
• MalfunctionApr 6, 2021Computer Software Problem; Computer Software Problem

  ON MARCH 15, 2021 FUJIFILM MEDICAL SYSTEMS USA, INC. (FMSU) WAS MADE AWARE OF AN INCIDENT WITH SYNAPSE PACS. WHEN A USER OPENS A STUDY WITH AN URL-CALL FROM THEIR HIS (SAP), IMAGES ARE SHOWN FROM PATIENT A BUT THE INFORMATION PANE SHOWS STUDIES FROM PATIENT B. ON (B)(6) 2021 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; HOWEVER THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624344 ↗
• MalfunctionMar 24, 2021Computer Software Problem; Computer Software Problem

  ON MARCH 04, 2021 FUJIFILM MEDICAL SYSTEMS USA, INC. (FMSU) SERVICE DEPARTMENT RECEIVED A CUSTOMER INQUIRY FOR ASSISTANCE WITH SYNAPSE PACS. WHEN A USER OPENS A STUDY USING THE EMR URL, THE VIEWER DID NOT REFRESH THE STUDY LIST, INSTEAD SHOWING THE PREVIOUS PATIENT'S STUDY LIST WITH THE NEW PATIENT'S IMAGES LOADED IN THE VIEWPORTS ON (B)(6) 2021 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; HOWEVER THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11560752 ↗
• MalfunctionFeb 17, 2021Computer Software Problem

  ON (B)(6) 2021 FUJIFILM MEDICAL SYSTEMS USA, INC. (FMSU) SERVICE DEPARTMENT RECEIVED A CUSTOMER INQUIRY FOR ASSISTANCE WITH SYNAPSE PACS. THE POWERJACKET WINDOW CAN BECOME OUT OF SYNC AND DISPLAY THE DETAILS FOR THE PREVIOUSLY LOADED PATIENT. ON FEBRUARY 05, 2021 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. ON FEBRUARY 11, 2021, THE RISK ASSESSMENT WAS REVISED BASED ON AVAILABILITY OF NEW INFORMATION. THE ISSUE IS CONSIDERED HIGHLY DETECTABLE BY A HEALTHCARE PROFESSIONAL; HOWEVER THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11337324 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160108, K190232, K243647, K261713. One submission often covers many models, so check the product and lot details in each record.

• Z-1348-2021 · Mar 2, 2021 · Open, Classified
  Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specification
• Z-0918-2021 · Dec 11, 2020 · Terminated
  FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifi
• Z-0282-2021 · Sep 11, 2020 · Terminated
  Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is network
• Z-0878-2021 · Sep 11, 2020 · Open, Classified
  Synapse PACS Software Versions 5.1 and higher
• Z-2471-2020 · May 22, 2020 · Open, Classified
  Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)