SureSigns VM6Recalls & reported problems across all models

We found 2 models of SureSigns VM6 by Philips Medical Systems Hsg in the FDA's device registry (GUDID). Together they are named in 45 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2019 and Sep 1, 2026 — classified as 1 injury, 44 malfunctions.

The most frequently reported specific device problem is “No Audible Alarm” (10 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

SureSigns VM6 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 13, 2018Open, Classified

   Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be replaced every 3 years or upon reaching 300 charge-discharge cycles. Although the Philips SureSigns VS & VM Monitors and View Station (VSV) can display actual information on either or both battery age and charge-discharge cycles, the existing labeling does not include full instructions on how to use this information to determine when to replace the battery. An overheated battery may in turn cause the device case to overheat and possibly melt or cause the device to ignite, which can cause injury to a patient, nearby users, or cause damage to property.

   Z-2895-2018 · Root cause: Labeling design · names 2 of these models · Recall details · FDA record ↗

Most reported SureSigns VM6 problems

SureSigns VM6 models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SureSigns VM6 SureSigns VM 6 patient Monitor

  MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
  1 recall33 reports
• SureSigns VM6 SureSigns VM 6 Patient Monitor

  MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
  1 recall12 reports

Recent SureSigns VM6 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026No Audible Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50548206 ↗
• MalfunctionJun 15, 2026Imprecise or Erratic Results

  PHILIPS RECEIVED A COMPLAINT ON AN SURESIGNS VM 6 PATIENT MONITOR INDICATING THAT THE NURSE FOUND THE ECG MONITORING DATA WAS INACCURATE. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25511020 ↗
• MalfunctionMar 24, 2026Incorrect Measurement

  IT WAS REPORTED THAT THE SURESIGNS VM 6 PATIENT MONITOR WAS PROVIDING INACCURATE SPO2 VALUES. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681308 ↗
• MalfunctionMar 18, 2026Incorrect Measurement

  IT WAS REPORTED THAT THE SURESIGNS VM 6 PATIENT MONITOR WAS PROVIDING INACCURATE ECG VALUES. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626860 ↗
• MalfunctionApr 2, 2025No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THE SURESIGNS VM 6 PATIENT MONITOR DISPLAYS A SPEAKER MALFUNCTION INOP ERROR MESSAGE AND IS UNABLE TO PRODUCE SOUND. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21749939 ↗
• MalfunctionFeb 26, 2025No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED THAT THE SURESIGNS VM 6 PATIENT MONITOR WAS PRODUCING NO SOUND. THE DEVICE WAS NOT IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471904 ↗
• MalfunctionJul 17, 2024No Audible Alarm; No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE SURESIGNS VM 6 PATIENT MONITOR INDICATING THAT THERE WAS AN AUDIO ERROR "SYSTEM ERROR 1036", WHICH INDICATED THAT THE SPEAKER WAS NOT PRODUCING SOUND. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19760004 ↗
• MalfunctionJan 25, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED THERE WAS A SPEAKER MALFUNCTIONING ERROR AND NO SOUND WAS BEING EMITTED FROM THE DEVICE. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME OF THE EVENT. NO ADVERSE EVENT OR PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18578713 ↗
• MalfunctionNov 20, 2023No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED THAT AN ALARM DID NOT WORK AFTER THE BOOTING UP OF THE SURESIGNS VM6 PATIENT MONITOR. THE DEVICE WAS NOT IN USE MONITORING A PATIENT AT THE TIME OF THE REPORTED ISSUE. NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18168998 ↗
• MalfunctionNov 7, 2023No Audible Alarm; No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE SURESIGNS VM 6 PATIENT MONITOR INDICATING A NO ALARM SOUND. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18084827 ↗
• MalfunctionSep 27, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  PHILIPS RECEIVED A COMPLAINT ON THE SURESIGNS VM 6 PATIENT MONITOR INDICATING SPEAKER FAILURE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17826036 ↗
• MalfunctionMay 23, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED THERE IS A SPEAKER FAILURE, IT IS POSSIBLE THE LOUDSPEAKER IS DAMAGED. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16984000 ↗
• MalfunctionFeb 10, 2023No Audible Alarm; No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE SURESIGNS VM 6 PATIENT MONITOR SN (B)(6) INDICATING AN AUDIO ERROR "DEFECTIVE SPEAKER". THE DEVICE WAS NOT IN USE MONITORING A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT INVOLVING A PATIENT OR USER WAS REPORTED. A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT ONSITE TO EVALUATE THE DEVICES IN QUESTION.THE BIOMEDICAL ENGINEER (BMED) ONSITE CONFIRMED AN AUDIO ERROR. THE (FSE) CONFIRMED THE CUSTOMERS ALLEGATION AND FOUND THE SPEAKER TO BE COMPLETELY OUT OF SOUND. THE (FSE) REPLACED THE MAINBOARD AND SOUND SPEAKER FOR THEIR MALFUNCTION. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS CONFIRMED.BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME. AFTER SPEAKER ASSEMBLY AND MAINBOARD REPLACEMENT THE DEVICE WAS RETURNED TO FUNCTIONAL USE WITH NO FURTHER ISSUES IDENTIFIED. THE DEVICE REMAINS AT THE CUSTOMER SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16352166 ↗
• MalfunctionJan 20, 2023No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED AN AUDIO ERROR INDICATING A DEFECTIVE SPEAKER. THE DEVICE WAS IN USE MONITORING A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT INVOLVING A PATIENT OR USER WAS REPORTED. A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT ONSITE TO EVALUATE THE DEVICES IN QUESTION. THE FOLLOWING TECHNICAL INVESTIGATION WAS PERFORMED BY INTERVIEWING THE BIOMEDICAL ENGINEER ONSITE (BME): THE (BME) IDENTIFIED AN ISSUE WITH THE MAINBOARD. AN ONSITE VISIT WAS SCHEDULED TO REPAIR THE UNIT. THE (FSE) CONFIRMED THE UNIT WAS COMPLETELY OUT OF SOUND AND THERE WAS A SPEAKER MALFUNCTION INOP. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS CONFIRMED. THE REPORTED PROBLEM WAS CONFIRMED. THE MAINBOARD WAS REPLACED TO RESOLVE THE ISSUE AND THE DEVICE WAS RETURNED TO FUNCTIONAL USE WITH NO FURTHER ISSUES IDENTIFIED. THE DEVICE REMAINS AT THE CUSTOMER SITE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218076 ↗
• MalfunctionOct 21, 2022No Audible Alarm

  THE CUSTOMER REPORTED THAT EVEN WHEN INCREASING THE SOUND VOLUME TO MAXIMUM, THE DEVICE DOES NOT EMIT ONE SINGLE SOUND ANYMORE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15653729 ↗

Other Philips Medical Systems Hsg products

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