SureSigns VS4 863283 (UDI 00884838087095)Recalls & reported problems

Summary

The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 00884838087095), received between Nov 6, 2018 and Sep 14, 2026 — classified as 94 malfunctions.

The most frequently reported specific device problem is “No Audible Prompt/Feedback” (25 reports).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

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-2894-2018 · Root cause: Labeling design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 94 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Signal Artifact/Noise

  Philips received a complaint on the SureSigns VS4 NBP, SPO2 indicating that the devices O2 monitor has a ghost read. It is unknown if the device was in use at time of event, and there was no adverse event reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50758643 ↗
• MalfunctionSep 4, 2026Application Program Freezes or Fails to Launch

  The screen freezes on the monitoring screen, you have to remove the battery and in order to reset the device. The problem occurred several times despite replacing the battery. Please send us a motherboard as part of the contract.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50611586 ↗
• MalfunctionJun 23, 2026No Audible Prompt/Feedback

  PHILIPS RECEIVED A COMPLAINT ON A SURESIGNS VS4 NBP, SPO2 DEVICE INDICATING THAT DURING ROUTINE TESTING, THE DEVICE FAILED THE ALARM TEST. THERE WAS A SPEAKER MALFUNCTION. 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 25597901 ↗
• MalfunctionApr 20, 2026Unable to Obtain Readings

  IT WAS REPORTED THAT THE BLOOD PRESSURE (BP) CONTINUES TO INFLATE, BUT NO RESULTS ARE PROVIDED. 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 24927754 ↗
• MalfunctionApr 13, 2026Incorrect Measurement

  THE CUSTOMER REPORTED THAT THE UNIT IS FAILING NIBP ACCURACY TEST DURING A PREVENTIVE MAINTENANCE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24867674 ↗
• MalfunctionMar 25, 2026High Readings

  PHILIPS RECEIVED A COMPLAINT ON A SURESIGNS VS4 NBP, SPO2 INDICATING THAT THE DEVICE WAS DISPLAYING ELEVATED VITAL SIGN READINGS. UPON INITIAL FOLLOW-UP, FACILITY STAFF CLARIFIED THAT THE CONCERN INVOLVED HIGH BLOOD PRESSURE (NBP) READINGS OBSERVED OVERNIGHT. STAFF INDICATED THEY HAD ATTEMPTED TO USE A DIFFERENT MACHINE; HOWEVER, THEY WERE UNSURE WHETHER DIFFERENT HOSES OR CUFFS HAD BEEN USED DURING TROUBLESHOOTING. THE DEVICE WAS REPORTED TO BE IN CLINICAL USE. NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689433 ↗
• MalfunctionJan 26, 2026Incorrect Measurement

  PHILIPS RECEIVED A COMPLAINT ON A SURESIGNS VS4 INDICATING THAT THE BLOOD PRESSURE MEASUREMENTS TAKEN ARE INCORRECT. THE CUSTOMER STATED THE DEVICE WAS NOT BEING USED WITH PATIENTS. NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24178857 ↗
• MalfunctionDec 9, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE SPO2 MEASUREMENTS PROVIDED WERE INCORRECT. 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 23759472 ↗
• MalfunctionDec 5, 2025No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED THE SPEAKER NEEDED REPLACEMENT. IT IS UNKNOWN IF THERE WAS STILL SOUND PRESENT. PATIENT INVOLVEMENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727710 ↗
• MalfunctionNov 27, 2025No Audible Alarm; No Audible Prompt/Feedback; No Audible Alarm; No Audible Prompt/Feedback

  THE CUSTOMER REQUESTED A REPLACEMENT SPEAKER. IT IS UNKNOWN IF THE DEVICE PRODUCED SOUND AT THE TIME OF THE REPORT. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF EVENT, AND THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23665942 ↗
• MalfunctionNov 27, 2025No Audible Alarm; No Audible Prompt/Feedback; No Audible Alarm; No Audible Prompt/Feedback

  THE CUSTOMER REQUESTED A REPLACEMENT SPEAKER. IT IS UNKNOWN IF THE DEVICE PRODUCED SOUND AT THE TIME OF THE REPORT. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF EVENT, AND THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23664122 ↗
• MalfunctionNov 17, 2025No Audible Prompt/Feedback; No Audible Prompt/Feedback

  PHILIPS RECEIVED A COMPLAINT ON THE SURESIGNS VS4 INDICATING THAT THE SPEAKER DEFECTIVE. GOOD FAITH EFFORTS WERE MADE TO SEE IF THE SPEAKER PRODUCED SOUND AT TIME OF EVENT. IT IS UNKNOWN IF THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23574781 ↗
• MalfunctionNov 13, 2025No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THE DEVICE DISPLAYS A SPEAKER MALFUNCTION ERROR MESSAGE AND THERE WAS NO SOUND COMING FROM THE DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23541637 ↗
• MalfunctionNov 3, 2025No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED THAT THE SURESIGNS VS4 DEVICE WAS NOT PRODUCING ANY SOUND. THE DEVICE WAS NOT 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 23449480 ↗
• MalfunctionOct 24, 2025No Audible Alarm; No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE SURESIGNS VS4 NBP, SPO2 INDICATING THAT THE UNIT AUDIO FAILED AND SPEAKER MALFUNCTION INOP ON SCREEN. THE DEVICE WAS NOT IN CLINICAL USE AT TIME OF EVENT AND NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23383750 ↗
• MalfunctionOct 20, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  PHILIPS RECEIVED A COMPLAINT ON THE SURESIGNS VS4 NBP, SPO2 INDICATING PULSOX LOW PROFUSION INDEX- PULSOX INTERFERENCE DETECTED- AND THAT THERE WERE INACCURATE SPO2 READINGS ON THE VS4. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336143 ↗
• MalfunctionAug 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PHILIPS RECEIVED A COMPLAINT ON THE SURESIGNS VS4 NBP, SPO2 INDICATING THAT SPO2 WAS READING INCORRECTLY. 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 22855921 ↗
• MalfunctionJul 10, 2025No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THERE WAS AN AUDIO FAILURE. IT WAS CONFIRMED THERE WAS NO SPEAKER MALFUNCTION INOPERATIVE ERROR MESSAGE PRESENT. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF EVENT, AND THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470762 ↗
• MalfunctionJul 10, 2025No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED THE SURESIGNS VS4 DISPLAYS THE TECHNICAL ALARM "SPEAKER FAULT". IT IS UNKNOWN IF THE DEVICE PRODUCED 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 22467806 ↗
• MalfunctionNov 11, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED THAT THE SURESIGNS VS4 NBP, SPO2 HAD A DEFECTIVE LOUDSPEAKER. A GOOD FAITH EFFORT (GFE) WAS PERFORMED TO CLARIFY IF THE SPEAKER PRODUCED SOUND AT THE TIME OF THE EVENT, BUT THE INFORMATION WAS UNKNOWN. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20651616 ↗
• MalfunctionNov 5, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback

  PHILIPS RECEIVED A COMPLAINT ON THE SURESIGNS VS4 INDICATING THAT THE DEVICE READS SPEAKER MALFUNCTION. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20612009 ↗
• MalfunctionOct 16, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THE SURESIGNS VS4 NBP, SPO2 MONITOR HAS A FROZEN SCREEN. THE DEVICE WAS IN USE AT TIME OF THE EVENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461696 ↗
• MalfunctionAug 22, 2024No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT THERE WAS NO ALARM SOUND. IT IS UNKNOWN IF 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 20032096 ↗
• MalfunctionJun 3, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback

  PHILIPS RECEIVED A COMPLAINT ON THE SURESIGNS VS4 NBP, SPO2 MONITOR INDICATING THE SYSTEM THAT THE SYSTEM AUDIO IS NOT WORKING. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19447229 ↗
• MalfunctionMay 14, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED THE SURESIGNS VS4 MONITOR WAS PRESENTED WITH A SPEAKER MALFUNCTION INOP ERROR. THE DEVICE WAS NOT IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19308021 ↗