SureSigns VS2+Recalls & reported problems across all models
Philips Medical Systems Hsg · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 56
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of SureSigns VS2+ by Philips Medical Systems Hsg in the FDA's device registry (GUDID). Together they are named in 56 adverse event reports in the FDA's MAUDE database, received between Dec 8, 2017 and Jul 22, 2025 — classified as 56 malfunctions.
The most frequently reported specific device problem is “No Audible Prompt/Feedback” (22 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. 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
Reports received per month, all models
Most reported SureSigns VS2+ problems
Device problems
- No Audible Prompt/Feedback22
- No Audible Alarm10
- Application Program Freezes or Fails to Launch6
- Device Displays Incorrect Message3
- Device Alarm System2
- Inaudible or Unclear Audible Prompt/Feedback2
- Output Problem2
- Therapeutic or Diagnostic Output Failure2
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- No Known Impact Or Consequence To Patient15
- No Patient Involvement3
- Insufficient Information1
- No Consequences Or Impact To Patient1
SureSigns VS2+ models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SureSigns VS2+ 863278COMPUTER, BLOOD-PRESSURE40 reports
- SureSigns VS2+ 863279COMPUTER, BLOOD-PRESSURE16 reports
Recent SureSigns VS2+ adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2025No Audible Prompt/Feedback; No Audible Prompt/Feedback
THE CUSTOMER REPORTED DURING TESTS PERFORMED THE SURESIGNS VS2+ INDICATING ERROR MESSAGE SPEAKER FAULT AUDIO PROBLEM . THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED. IT IS UNKNOWN IF THERE WAS SOUND PRODUCED BY THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22562970 ↗MalfunctionMar 20, 2025No Audible Alarm; No Audible Alarm
IT WAS REPORTED THAT THE DEVICE HAS A FAULTY SPEAKER, AND THE SPEAKER WAS COMPLETELY OUT OF SOUND. 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 21651799 ↗MalfunctionNov 15, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback
IT WAS REPORTED THAT THERE WAS AN AUDIO ERROR. 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 20696640 ↗MalfunctionJun 13, 2024No Audible Alarm; No Audible Alarm
PHILIPS RECEIVED A COMPLAINT ON THE SURESIGNS VS2+ NBP/SPO2 MONITOR INDICATING THE SYSTEM DISPLAYED A SPEAKER MALFUNCTION. THE DEVICE WAS 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 19529727 ↗MalfunctionMar 22, 2024Device Alarm System; No Audible Alarm; Device Alarm System; No Audible Alarm
THE CUSTOMER REPORTED THAT THE EQUIPMENT IS ALARMING "AUDIO ERROR". NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18959361 ↗MalfunctionFeb 23, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback
THE CUSTOMER REPORTED AN AUDIO FAILURE WITH THE SYSTEM. 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 18768775 ↗MalfunctionFeb 20, 2024No Audible Alarm; No Audible Alarm
THE CUSTOMER REPORTED A SPEAKER MALFUNCTION, NO ALARM COMING FROM THE DEVICE. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18737587 ↗MalfunctionOct 29, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback
THE CUSTOMER REPORTED THAT THERE WAS AN AUDIO FAILED ERROR MESSAGE. THE DEVICE WAS NOT IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18027151 ↗MalfunctionOct 10, 2023Device Fell; Device Fell
THE CUSTOMER REPORTED THAT THE EQUIPMENT CAME OFF THE CART AND FELL TO THE FLOOR. 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 17908429 ↗MalfunctionSep 27, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback
THE CUSTOMER REPORTED THAT THERE WAS AUDIO 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 17826255 ↗MalfunctionSep 13, 2023Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem
THE CUSTOMER REPORTED THAT THEY ARE GETTING AN ERROR MESSAGE INDICATING AUDIO 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 17738773 ↗MalfunctionAug 2, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback
THE CUSTOMER REPORTED THAT THE EQUIPMENT DISPLAYS AN AUDIO FAILURE WARNING. 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 17440136 ↗MalfunctionMay 17, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback
PHILIPS RECEIVED A COMPLAINT ON THE DEVICE INDICATING THEY FOUND AN AUDIO FAILURE ALARM. 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 REMOTE SERVICE ENGINEER (RSE) REMOTELY INTERVIEWED THE BIOMEDICAL MEDICAL ENGINEER (BMED) WHO WAS ONSITE TO EVALUATE THE DEVICE IN QUESTION. THE (BMED) CONFIRMED THE UNIT HAD NO SOUND COMING FROM THE UNIT AT ALL AND THERE WAS A SPEAKER INOPERATIVE "AUDIO FAILED" MESSAGE PRESENT ON THE SCREEN. THE (BMED) REPLACED THE MAIN BOARD TO RESOLVE THE ISSUE. BASED ON THE INFORMATION AVAILABLE, THE REPORTED PROBLEM WAS CONFIRMED. AFTER THE MAINBOARD REPLACEMENT 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 16945115 ↗MalfunctionMay 9, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback
PHILIPS RECEIVED A COMPLAINT ON THE SURESIGNS VS2+ NBP/SPO2 SN (B)(6) INDICATING THERE WAS A DISPLAYS ERROR AUDIO/LOUDSPEAKER ISSUE. THE DEVICE WAS 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 16896330 ↗MalfunctionJan 5, 2023No Audible Alarm; No Audible Alarm
STATEMENT OF THE REPORTED PROBLEM: THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS RESPONSE SERVICE ENGINEER (RSE) AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE SURESIGNS VS2+ NBP/SPO2/WIRELESS INDICATING THAT THE AUDIO FAILED AND AN INOP MESSAGE WAS DISPLAYED. THERE WAS NO REPORT OF A DEATH OR SERIOUS INJURY, NOR WAS THERE A REPORT OF ANY ADVERSE IMPACT TO ANY USER OR PATIENT. FUNCTIONAL TESTING/SERVICE REPAIR/TECHNICAL INVESTIGATION: THE FOLLOWING FUNCTIONAL TESTS WERE PERFORMED: THE RSE SPOKE TO THE CUSTOMER AND DETERMINED THAT THE LOSS OF AUDIO WAS THE RESULT OF A FAILED SPEAKER. CONFIRMATION: BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS A FAILED SPEAKER. THE REPORTED PROBLEM WAS CONFIRMED. FURTHER ACTION DECISION: BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME. CLOSURE & PRODUCT DISPOSITION: SERVICEABLE ¿ REPLACEMENT PRODUCT PROVIDED: THE CUSTOMER PLACED AN ORDER FOR A NEW SPEAKER (SS MECHASY SPEAKER ASSY-FS PART NUMBER - 453564293611) AND IS TAKING RESPONSIBILITY FOR PERFORMING THE DEVICE REP
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16101948 ↗
Other Philips Medical Systems Hsg products
- Patient Information Center iX3 models · 1,836 reports
- SureSigns VS42 models · 103 reports · 9 recalls
- SureSigns VM62 models · 45 reports · 1 recall
- HeartStart3 models · 14 reports · 1 recall
- SureSigns VM82 models · 14 reports · 1 recall
- Temperature Probes3 models · 1 reports · 1 recall
- PageWriter5 models · 39 reports
- SureSigns VSi3 models · 25 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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