INTELEPACS 5Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI B228INTELEPACS0), received between Sep 28, 2017 and Dec 16, 2021 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2021Computer Software Problem; Computer Software Problem

  WHEN USING ADVANCED VISUALISATION TO RECONSTRUCT MR, CT AND PET IMAGES THAT CONTAIN NON-SQUARE PIXELS, THE RECONSTRUCTED IMAGE IS INCORRECT. NON-SQUARE PIXELS OCCUR WHEN THE ROW AND COLUMN PIXEL SPACING VALUES ARE DIFFERENT. MEASUREMENTS MADE ON THIS IMAGE ARE ALSO CONSEQUENTLY ERRONEOUS. THIS ISSUE DOES NOT AFFECT MEASUREMENTS MADE ON REGULAR 2D VIEWS. WHEN USING ADVANCED VISUALISATION IN THE ENHANCED VIEWER TO RECONSTRUCT MR AND CT IMAGES THAT HAVE NON-ORTHOGONAL VOLUME AXES (E.G. GANTRY TILT), LINEAR MEASUREMENTS WILL BE INCORRECT DUE TO THE USE OF AN INCORRECT FORMULA. THIS ONLY OCCURS FOR MEASUREMENTS MADE ON A RE-ORIENTED VIEW (E.G. MPR). INTELEVIEWER CAN BE AFFECTED WHEN USING THE EV ADVANCED VISUALISATION VIEW EMBEDDED INSIDE INTELEVIEWER (INTELEVIEWER VERSIONS 5.4.1.R1 AND LATER). HAZARD INVOLVED: WHEN THE SPECIFIC CIRCUMSTANCES DESCRIBED ABOVE OCCUR, THERE IS A POSSIBILITY OF DISPLAYING DISTORTED IMAGES ALONG WITH ERRONEOUS MEASUREMENTS. THE DISTORTION AND MEASUREMENT DIFFERENCE COULD AFFECT DECISIONS REGARDING PATIENT CARE. FOR ISSUE 1, THE MAXIMUM MEASUREMENT ERROR IS PROPORTIONAL TO THE RATIO OF ROW AND COLUMN PIXEL SPACINGS. NO PATIENT HARM HAS BEEN REPORTED AT THIS T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13017666 ↗
• MalfunctionOct 29, 2021Computer Software Problem; Missing Test Results; Computer Software Problem; Missing Test Results

  DESCRIPTION OF THE PROBLEM: THE ISSUE MAY BE TRIGGERED BY THE PRESENCE OF PRE-FORMATTED HTML TEXT IN HL7 REPORTS USING THE <PRE> TAG. THESE REPORTS WILL BE TRUNCATED WHEN THEY ARE RENDERED BY THE ENHANCED VIEWER PDF REPORT VIEWER, WHICH COULD LEAD TO INCOMPLETE REPORT CONTENT DISPLAYED TO THE ENHANCED VIEWER USER. THIS ISSUE WILL ONLY HAPPEN WHILE USING (B)(6) AND LATER VERSIONS OF THESE BROWSERS. THE IMPACT OF THE PROBLEM IS LIMITED TO THE ENHANCED VIEWER MODULE WHEN VIEWING REPORTS. FURTHERMORE, THE REPORTS STORED IN INTELEPACS ARE NOT IMPACTED BY THIS ISSUE, AND THEIR ENTIRE CONTENT CAN BE ACCESSED WITHIN INTELEBROWSER, INTELECONNECT OR INTELEVIEWER. REPORTS SENT EXTERNALLY THROUGH HL7 ARE NOT IMPACTED. WHEN THE SPECIFIC CIRCUMSTANCES DESCRIBED ABOVE OCCUR, THERE IS A POSSIBILITY THAT INCOMPLETE INFORMATION IS PRESENTED TO THE ENHANCED VIEWER USER. THE ABSENCE OF THE INFORMATION IN THE REPORT COULD AFFECT THE DECISIONS THEY MAKE REGARDING PATIENT CARE. NO PATIENT HARM HAS BEEN REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12724092 ↗
• MalfunctionJul 16, 2021Loss of Data; Loss of Data

  ALL VERSIONS OF INTELEPACS SOFTWARE WITH SPECIFIC MISCONFIGURATION TO PERFORM HTML NORMALIZATION ON OUTBOUND PLAIN TEXT REPORT COULD CAUSE REPORTS TO BE TRUNCATED. THE ISSUE MAY BE TRIGGERED BY THE PRESENCE OF THE LESS THAN CHARACTER (<) IN A PLAIN TEXT REPORT RECEIVED FROM AN EXTERNAL SYSTEM. WHEN A REPORT IS BEING FORWARDED EXTERNALLY TO A THIRD SYSTEM, AN INCORRECTLY CONFIGURED HTML TAG NORMALIZATION STEP MAY ERRONEOUSLY TREAT UNESCAPED LESS THAN (<) SIGNS AS TAGS AND REMOVE THE TEXT THAT FOLLOWS UNTIL THE NEXT GREATER THAN (>) SIGN FROM THE ORIGINAL REPORT RECEIVED BY INTELEPACS. THE IMPACT OF THE PROBLEM IS LIMITED TO SPECIFIC OUTBOUND COMMUNICATION CHANNELS THAT ARE MISCONFIGURED. FURTHERMORE, THE REPORTS STORED IN INTELEPACS ARE NOT IMPACTED BY THIS ISSUE, AND THEIR ENTIRE CONTENT CAN BE ACCESSED WITHIN INTELEPACS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12182909 ↗
• MalfunctionJun 12, 2020Output Problem; No Apparent Adverse Event; Program or Algorithm Execution Failure; Output Problem; No Apparent Adverse Event; Program or Algorithm Execution Failure

  A HAZARD MAY ARISE WHEN NON-DICOM COMPLIANT JPEG-2000-COMPRESSED IMAGES ARE RECEIVED BY THE (B)(6) COMPONENT WITH DICOM BIT DEPTH (BITS STORED TAG) THAT DOES NOT MATCH THE BIT DEPTH IN THE PIXEL DATA CODESTREAM. THESE IMAGES ARE DECOMPRESSED WITH A LOSS OF PRECISION IN THE IMAGE DATA WHICH CAN LEAD TO FAILING IMAGE REGISTRATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10148184 ↗
• MalfunctionFeb 25, 2020Failure to Back-Up; Loss of Data; Failure to Back-Up; Loss of Data

  A USER REPORTED THAT APPROXIMATELY 1000 STUDIES WERE LOST FROM THE PACS STORAGE AND A REFERRING PHYSICIAN WAS UNABLE TO VIEW IMAGES. RADIOLOGIST REPORTS FOR THESE DELETED STUDIES REMAINED AVAILABLE. PRELIMINARY ANALYSIS DETERMINED THE PROBLEM IS DUE TO A CONFIGURATION KEY THAT WAS ACTIVATED IN COMBINATION WITH A SOFTWARE BUG. WHEN THE FEATURE FORCEGLOBALSTUDYDELETION IS ENABLED, ANY SERIES DELETIONS THAT OCCUR ON A SERVER ARE AUTOMATICALLY ELEVATED TO A SYSTEM-LEVEL STUDY DELETION. THIS SYSTEM-LEVEL DELETION BYPASSES EXISTING MITIGATION POLICIES (I.E., ARCHIVE POLICIES) ON OTHER SERVERS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9751805 ↗
• MalfunctionJan 21, 2020No Apparent Adverse Event; Patient Data Problem; No Visual Prompts/Feedback; No Apparent Adverse Event; Patient Data Problem; No Visual Prompts/Feedback

  FOLLOWING INTERNAL TESTING, INTELERAD HAS DETECTED A PROBLEM THAT COULD OCCUR ON INTELEPACS SOFTWARE (INTELEVIEWER MODULE) AND, PROVIDING ADDITIONAL INFORMATION REGARDING THIS PROBLEM. DESCRIPTION OF THE PROBLEM: WHEN THE USER HAS OPENED MULTIPLE ORDERS IN INTELEVIEWER TO DICTATE FOR DIFFERENT PATIENTS, AND SWITCHES RAPIDLY (SUBSECOND) BETWEEN THEM MANY TIMES, IT IS POSSIBLE FOR THE VIEWER TO DISPLAY IMAGES FROM ONE PATIENT WHILE SHOWING THE PATIENT RECORD TAB AND DICTATION SYSTEM FOR ANOTHER. IF THE USER TAKES ANY ACTION IN THE VIEWER (INCLUDING WINDOW FOCUS), THE VIEWS (IMAGES AND DICTATION) WILL RESYNCHRONIZE WITH THE PATIENT RECORD TAB. THIS DESYNCHRONIZATION SITUATION CAN ALSO ARISE WHEN USING A 3RD PARTY DICTATION SYSTEM, IF THE RADIOLOGIST SWITCHES TO THE IMAGE VIEWING WINDOWS OF A DIFFERENT PATIENT USING THE OPERATING SYSTEM AND DOES NOT INTERACT AT ALL WITH THE VIEWER, WHILE INTELEVIEWER IS WAITING FOR THE DICTATION SYSTEM TO COMPLETE A PREVIOUS SWITCH FROM ONE PATIENT TO ANOTHER. AGAIN, IF THE USER TAKES ANY ACTION IN THE VIEWER (INCLUDING WINDOW FOCUS), ALL OF THE VIEWS WILL RESYNCHRONIZE. ROOT CAUSE ANALYSIS: THE CURRENT ISSUE (IP-107498) WAS INTRODUCED BY THE CODE CHAN

  Patient problems: Misdiagnosis

  MAUDE report 9611265 ↗
• MalfunctionApr 30, 2019Device Displays Incorrect Message; No Apparent Adverse Event; Patient Data Problem; Device Displays Incorrect Message; No Apparent Adverse Event; Patient Data Problem

  INTELERAD HAS IDENTIFIED A SOFTWARE PROBLEM IN ITS (B)(6) SOFTWARE. THE ISSUE IS TRIGGERED BY THE PRESENCE OF THE PIPE CHARACTER ( / ) IN THE REPORT. IF THE TEXT OF AN INTELEPACS-GENERATED REPORT CONTAINS AN UNQUOTED PIPE CHARACTER (I.E. /) THEN QUERYING FOR IT VIA HL7 WILL RESULT IN A REPORT THAT APPEARS TO BE TRUNCATED AT THAT POINT. ONLY CLIENTS WITH VERSIONS 4-11-1 AND LATER USING MULTI METHOD REPORTING OR INTELEDICTATION AS WELL AS THE HL7GATEWAYSERVER DYNAMIC REPORT RENDERER ARE AFFECTED. THIS ISSUE COULD IMPACT THE PATIENT SAFETY BECAUSE IT CAN RESULT IN MISSING REPORT TEXT. WHILE IN SOME CASES IT MAY BE OBVIOUS, IN OTHER CASES IT COULD RESULT IN LOST ADDENDA, WHICH WOULD NOT BE VISIBLE TO THE HEALTH PROFESSIONAL WHO COULD MAKE A DIAGNOSIS WITH INCOMPLETE OR MISSING DATA. ROOT CAUSE ANALYSIS: ROOT CAUSE ANALYSIS: THE DYNAMIC REPORT RENDERER OF HL7GATEWAYSERVER APPLICATION FAILED TO ESCAPE A SPECIAL CHARACTER IN A REPORT, CAUSING THE HL7 OBSERVATION FIELD TO BE UNEXPECTEDLY TRUNCATED WHEN RETRIEVING REPORTS THROUGH HL7. THIS ONLY AFFECTS REPORTS STORED IN THE REPORT ACCESS API (I.E., MMR OR INTELEDICTATION), WHERE THE CLIENT IS USING A DYNAMIC REPORT RENDERER. AFFECTED SOFTWA

  Patient problems: Misdiagnosis

  MAUDE report 8566453 ↗
• MalfunctionNov 30, 2017Display or Visual Feedback Problem; Display or Visual Feedback Problem

  INTELERAD HAS BEEN MADE AWARE OF A PROBLEM WHICH COULD BE A POSSIBLE PATIENT SAFETY: THE ISSUE IS TRIGGERED BY THE PRESENCE OF THE LESS THAN CHARACTER (<) IN THE REPORT. WHEN VIEWING A REPORT, THE LESS THAN CHARACTER IS NOT PRESENT WHILE IT WAS THERE IN THE ORIGINAL REPORT RECEIVED BY INTELEPACS. IN OTHER CASES, WHEN THE CHARACTER IS PRESENT IN A COMBINATION WITH OTHER CHARACTERS, PARTS OF THE REPORT TEXT FOLLOWING THE LESS THAN CHARACTER ARE NOT DISPLAYED DEPENDING ON THE INTELERAD APPLICATION USED BY THE END-USER TO REVIEW THE REPORTS. NO PATIENT WAS REPORTED IMPACTED BY THE PROBLEM. THIS REPORT IS SUBMITTED PREVENTIVELY. TICKET CASE ASSOCIATED: (B)(4). INVESTIGATION DETAILS IS DOCUMENTED IN (B)(4): IN INTELEVIEWER, WHEN VIEWING A REPORT CONTAINING THE LESS THAN (<) CHARACTER WHICH IS NOT PROPERLY FORMATTED FOR HTML, THE SYMBOL WILL NOT BE DISPLAYED. THIS CAN CHANGE THE MEANING OF THE REPORT. ROOT CAUSE: WHEN PLAIN TEXT REPORTS ARE RECEIVED FROM AN EXTERNAL SOURCE, ESCAPING OF HTML CHARACTERS SHOULD BE PERFORMED. THIS BEHAVIOUR IS CONTROLLED BY CONFIGURATION THAT WAS NOT SET CORRECTLY FOR THIS INTEGRATION. CATEGORIES OF REPORTS: INTELEPACS CAN RECEIVE REPORTS FROM MULTIPLE SOURCE

  Patient problems: Misdiagnosis

  MAUDE report 7072814 ↗
• MalfunctionSep 28, 2017Display or Visual Feedback Problem; Display or Visual Feedback Problem

  NO PATIENT INCIDENT REPORTED AT THIS MOMENT - THIS ISSUE IS DOCUMENTED AS A PRECAUTION. CONTEXT: INTELERAD HAS IDENTIFIED A SOFTWARE PROBLEM WITH THE MAGNIFICATION GLASS TOOL WHICH, IN SOME INSTANCES, DISPLAYS A DIFFERENT IMAGE THAN THE ONE CURRENTLY BEING SHOWN IN THE SELECTED VIEWPORT. IT APPEARS THAT THE TOOL IS DISPLAYING A MAGNIFIED IMAGE FOR A DIFFERENT SLICE OF THE SERIES. THIS COULD POTENTIALLY DELAY A DIAGNOSIS. THIS PROBLEM WAS REPORTED BY AN INTELERAD EMPLOYEE WHILE AT A CLIENT SITE. INVESTIGATION: (B)(4). THE SORTING ORDER OF AN IMAGE STACK IS NOT TAKEN INTO ACCOUNT BY THE MAGNIFICATION GLASS TOOL. IF THE USER IS USING REVERSE ORDERING (EITHER MANUALLY SELECTED OR THROUGH A PREFERENCE IN THE CASE OF TOMOSYNTHESIS) AND THEN USES THE MAGNIFICATION GLASS TOOL, THE IMAGE SHOWN IN THE TOOL WILL NOT BE THE ONE IN THE CURRENT VIEWPORT BUT RATHER THE CORRESPONDING POSITION FROM THE OPPOSITE END OF THE STACK. THIS DEFECT APPLIES TO ANY MODALITY WITH A STACK OF IMAGES, EX. TOMOSYNTHESIS, CT. THE DISCREPANCY IS HIGHLY DETECTABLE BY USER AND IS EXTREMELY UNLIKELY TO LEAD TO HARM TO THE PATIENT. DESCRIPTION OF HAZARDOUS SITUATION IN USE OF THE DEVICE: INCORRECT IMAGE BEING SHOWN WHI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6901432 ↗