ZOOM® LATITUDE® 3120 (UDI 00802526564703)Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00802526564703), received between Oct 2, 2017 and Dec 12, 2022 — classified as 1 death, 2 injuries, 62 malfunctions.

The most frequently reported specific device problem is “Defective Device” (30 reports).

4 FDA recall records name this device's identifier, 4 still open.

8 other recalls cover devices cleared under the same FDA submission (P910077); 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. Nov 30, 2023Class IIOpen, Classified

   The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly, with a year in the 1990s.

   Z-0673-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jul 7, 2022Class IIOpen, Classified

   There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.

   Z-1670-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Jul 7, 2022Class IIOpen, Classified

   There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.

   Z-1669-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Jul 7, 2022Class IIOpen, Classified

   There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.

   Z-1671-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT A SMALL PUFF OF SMOKE CAME OUT FROM THE PROGRAMMER WHEN POWERED ON AND BURNING SMELL WAS OBSERVED. NO ADVERSE EFFECT WAS REPORTED. THE PROGRAMMER WAS BEING RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15963970 ↗
• DeathNov 30, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THIS PROGRAMMER STARTED SMOKING UPON PLUGGING IN. AS OF THIS TIME, THIS PROGRAMMER REMAINS IN SERVICE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15889047 ↗
• MalfunctionJul 28, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THIS PROGRAMMER EMITTED FUME WHEN THE POWER CABLE WAS CONNECTED. NO ADVERSE PATIENTS EFFECTS WERE REPORTED. THE PROGRAMMER WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15122653 ↗
• MalfunctionApr 20, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT WHEN THE PROGRAMMER WAS STARTED, THE SCREEN DID NOT LIGHT UP AND THERE WAS A SMOKE FROM THE EDGE OF THE SCREEN. FURTHERMORE THE PROGRAMMER WILL BE REPLACED AND RETURNED FOR REPAIR/ANALYSIS. NO ADVERSE PATIENT EFFECT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14164167 ↗
• MalfunctionMar 2, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THE PROGRAMMER MADE A CLICK TONE, THE SCREEN TURNED BLACK AND PRESENTED A BURNT SMELL. FURTHERMORE THE PROGRAMMER WILL BE REPLACED AND RETURNED FOR REPAIR/ANALYSIS. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13656435 ↗
• MalfunctionFeb 6, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THE PROGRAMMER COULD NOT BE TURNED ON AND IT WAS ACCOMPANIED BY SPECIAL SMELL. THE PHYSICIAN SUSPECTED ELECTRONIC COMPONENTS BURNED OUT. NO ADVERSE PATIENT EFFECT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13467427 ↗
• InjuryJan 22, 2022Date/Time-Related Software Problem; Date/Time-Related Software Problem

  IT WAS REPORTED THAT THIS PATIENT PASSED OUT AND WAS ADMITTED TO THE HOSPITAL. UPON REVIEW OF DEVICE DATA, IT WAS OBSERVED THAT THIS PROGRAMMER RESET THE PATIENT'S DEVICE AND CAUSED EPISODE DATES TO BE SAVED UNDER A YEAR OTHER THAN CURRENT. IT WAS NOTED THE PROGRAMMER WAS LOCATED AT THE PHYSICIAN'S OFFICE, SO NOT SURE HOW LONG THE DEVICE HAD BEEN RESET TO THAT DATE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PROGRAMMER IS NO LONGER IN USE.

  Patient problems: Syncope/Fainting

  MAUDE report 13326864 ↗
• MalfunctionNov 7, 2021Unexpected Therapeutic Results; Material Integrity Problem; Unexpected Therapeutic Results; Material Integrity Problem

  IT WAS REPORTED THAT DURING A DEVICE FOLLOW-UP, THE PHYSICIAN PERFORMED A THRESHOLD TEST. HOWEVER, THE PACEMAKER-DEPENDENT PATIENT WENT INTO ASYSTOLE, WITH DIZZINESS AND MALAISE. THE PROGRAMMER TOUCHSCREEN WOULD NOT RESPOND SO THE PHYSICIAN COULD NOT STOP THE TEST IMMEDIATELY. THE PATIENT RECOVERED WITH NO INTERVENTION OR ADDITIONAL ADVERSE EFFECTS. THE PROGRAMMER WILL BE RETURNED FOR ANALYSIS AND REPAIR.

  Patient problems: Asystole; Dizziness; Malaise

  MAUDE report 12756325 ↗
• MalfunctionOct 28, 2021Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE PROGRAMMER HAD SMOKE EMERGED ON THE SIDE UPON START UP BUT THERE NO FIRE AND IT DOESN'T FEEL HOT TO TOUCH. REP UNPLUGGED THE PROGRAMMER AND WILL RETURN THE PRODUCT. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12716706 ↗
• MalfunctionSep 22, 2021Power Problem; Power Problem

  IT WAS REPORTED THAT THE PROGRAMMER PRESENTED A RUBBER BURNING SMELL AND TURNED OFF BY IT SELF. ALSO, SOME SMOKE WAS OBSERVED. FURTHERMORE THE PROGRAMMER WILL BE REPLACED AND RETURNED FOR REPAIR/ANALYSIS. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12516503 ↗
• MalfunctionSep 16, 2021Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT 3120 PROGRAMMER BLEW UP WHEN ATTEMPTING TO TURN ON. FURTHERMORE THE PROGRAMMER WILL BE REPLACED AND RETURNED FOR REPAIR/ANALYSIS. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12481613 ↗
• MalfunctionJul 28, 2021Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT WHEN TURNING ON THE PROGRAMMER SCREEN SUDDENLY WENT BLACK AND THERE WAS A SMELL OF BURNING. FURTHERMORE THE PROGRAMMER WILL BE REPLACED AND RETURNED FOR REPAIR/ANALYSIS. NO ADVERSE PATIENTS EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12243050 ↗
• MalfunctionJun 25, 2021Power Problem; Power Problem

  IT WAS REPORTED THAT THE PROGRAMMER SOCKET WAS BURNED OUT AND DID NOT TURN ON. FURTHERMORE, THE PROGRAMMER WILL BE REPLACED AND RETURNED FOR REPAIR/ANALYSIS. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12071946 ↗
• MalfunctionJun 25, 2021Power Problem; Power Problem

  IT WAS REPORTED THAT THE PROGRAMMER SMELLS LIKE BURNING RUBBER/PLASTIC WHEN TURNED ON. FURTHERMORE THE PROGRAMMER WILL BE REPLACED AND RETURNED FOR REPAIR/ANALYSIS. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12071943 ↗
• MalfunctionMar 23, 2021Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE PROGRAMMER WOULD NO LONGER TURNED ON, A WHITE SMOKE AND A BURNING SMELL EMANATED FROM THE POWER CONNECTOR. FURTHERMORE THE PROGRAMMER WILL BE REPLACED AND RETURNED FOR REPAIR/ANALYSIS. NO ADVERSE PATIENTS EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11557864 ↗
• MalfunctionFeb 23, 2021Power Problem; Power Problem

  IT WAS REPORTED THAT WHEN TURNING ON THE PROGRAMMER IT SMELLED LIKE IT WAS BURNING AND WAS NOT ABLE TO BOOT UP. FURTHERMORE, THE PROGRAMMER WILL BE REPLACED AND RETURNED FOR REPAIR/ANALYSIS. NO ADVERSE PATIENTS EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11369675 ↗
• InjuryFeb 23, 2021Application Program Problem; Interrogation Problem; Application Program Problem; Interrogation Problem

  IT WAS REPORTED THAT THIS PATIENT UNDERWENT LEFT VENTRICULAR (LV) THRESHOLD TESTING, BUT THE HEALTH CARE PROFESSIONAL (HCP) WAS UNABLE TO TERMINATE THE THRESHOLD TEST. THE DEVICE RECORDED GREATER THAN TWO SECONDS OF ASYSTOLE, AND A LATER REPORT NOTED GREATER THAN TEN SECONDS OF ASYSTOLE. THE PATIENT HAD SYMPTOMS OF NEAR FAINTING. THE PROGRAMMER EXHIBITED AN ERROR MESSAGE. AFTER THIS, LV THRESHOLD TESTING WAS STOPPED, AND THE CHECK WAS COMPLETED. ONE REPORT NOTED THAT STAT PACE WAS PRESSED, BUT ANOTHER REPORT NOTED IT WAS NOT PRESSED. DEVICE DATA WAS PRESERVED AND SUBMITTED FOR BOSTON SCIENTIFIC ENGINEERING REVIEW. ENGINEERING ANALYSIS SHOWED THEY WERE UNABLE TO DETERMINE THE ROOT CAUSE OF WHY THE MESSAGE WAS DISPLAYED, BUT IT WAS INDICATIVE OF POOR TELEMETRY OR TELEMETRY NOISE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Presyncope; Syncope/Fainting

  MAUDE report 11369570 ↗
• MalfunctionJan 26, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THIS PROGRAMMER SMELLED BURNT AND STUNK UP THE WHOLE CLINIC. THE PROGRAMMER WILL BE RETURNED. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 11233981 ↗
• MalfunctionJan 26, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) GOT A SHOCK WHEN USING THIS PROGRAMMER IN INTERROGATING A PATIENT. THE HCP REMOVED THE WAND YET THE PATIENT ADVOCATE CLAIMED OF SEEING A SPARK AND SMOKE COMING OUT FROM THIS PROGRAMMER. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) THEN DISCUSSED NOT USING THE PROGRAMMER AND HAVE IT RETURNED FOR ANALYSIS. THE HCP AND FIELD REPRESENTATIVE THOUGHT OF STATIC ELECTRICITY, HOWEVER, THERE WAS AN OBSERVATION OF SPARK AND SMOKE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11233658 ↗
• MalfunctionJan 24, 2021Power Problem; Power Problem

  IT WAS REPORTED THAT THE PROGRAMMER HAD A CRACKLE SOUND, A SLIGHT BURNT SMELL AND THEN WOULD NO LONGER TURN ON. FURTHERMORE THE PROGRAMMER WILL BE REPLACED AND RETURNED FOR REPAIR/ANALYSIS. NO ADVERSE PATIENTS EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11220852 ↗
• MalfunctionJan 15, 2021Defective Device

  IT WAS REPORTED THAT THIS PROGRAMMER EMITTED AN AUDIBLE NOISE AND PRODUCED A BURNING SMELL UPON START UP. THE PROGRAMMER WAS THEN SENT BACK FOR ANALYSIS. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 11180476 ↗
• MalfunctionNov 1, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS PROGRAMMER HAD A BLACK SCREEN AND EMITTED SMOKE. THIS PROGRAMMER WAS SENT BACK. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10767898 ↗
• MalfunctionOct 21, 2020Defective Device; Device Displays Incorrect Message; Material Integrity Problem; Defective Device; Device Displays Incorrect Message; Material Integrity Problem

  IT WAS REPORTED THAT THIS PROGRAMMER EXHIBITED FROZEN SCREEN AND DISPLAYED ERROR CODES. TROUBLESHOOTING WAS DONE BUT UNSUCCESSFUL. IN ADDITION, THE PROGRAMMER EMITTED SLIGHT SMELL OF BURNING ELECTRONICS. THE PROGRAMMER WILL BE RETURNED. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10714373 ↗
• MalfunctionOct 21, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING USE OF THIS PROGRAMMER, THE DISPLAY SCREEN SUDDENLY WENT BLACK AND THERE WAS A NOTABLE BURNT SMELL. NO OTHER PHYSICAL ANOMALIES WITH THE UNIT HOWEVER MULTIPLE RESTART/RESETS WERE UNABLE TO RESOLVE THE ISSUES AND THE UNIT IS EXPECTED TO BE RETURNED FOR REPAIR. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10714224 ↗
• MalfunctionOct 13, 2020Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE PROGRAMMER DID NOT START UP. FURTHERMORE, SOME BURNING SMELL WAS ALSO NOTED COMING FROM THE PROGRAMMER. THE PROGRAMMER WAS RETURNED TO SALES OFFICE FOR FURTHER OBSERVATION. NO ADVERSE PATIENTS EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10674222 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P910077. One submission often covers many models, so check the product and lot details in each record.

• Z-1216-2023 · Feb 2, 2023 · Open, Classified
  LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
• Z-3260-2018 · Sep 10, 2018 · Terminated
  Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communic
• Z-1445-2012 · Feb 24, 2012 · Terminated
  Boston Scientific LATITUDE Patient Management System Communicator, Model 6476, Distributed by Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, Made in Malaysi
• Z-1096-2012 · Dec 19, 2011 · Terminated
  LATITUDE Patient management System, Model 6488, software version 7.2. It is indicated for use to remotely communicate with a compatible Boston Scientific pulse generator and transf
• Z-0333-2012 · Oct 12, 2011 · Terminated
  LATITUDE Patient Management System, Models 6441*, 6442*, 6465*, 6488 (USA). There are two software applications: the programmer software and the LATITUDE remote monitoring system
• Z-0037-2012 · Aug 12, 2011 · Terminated
  LATITUDE Paceart Integration Software, version 1.00 Model 6472. LATITUDE Paceart Integration is software and therefore does not have any serial numbers. However, the software ver
• Z-1631-2010 · Sep 10, 2009 · Terminated
  Boston Scientific, LATITUDE Communicator, Distributed by Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112. Models 6476 (USA) and 6468 (OUS)
• Z-0002-2007 · May 19, 2006 · Terminated
  Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with Guidant implantable p