SureSigns VSiRecalls & reported problems across all models
Philips Medical Systems Hsg · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 3 models of SureSigns VSi by Philips Medical Systems Hsg in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Feb 25, 2021 and Jun 23, 2025 — classified as 25 malfunctions.
The most frequently reported specific device problem is “No Audible Prompt/Feedback” (11 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 VSi problems
Device problems
- No Audible Prompt/Feedback11
- No Audible Alarm5
- Incorrect Measurement3
- Break1
- Device Fell1
- Inaudible or Unclear Audible Prompt/Feedback1
- Insufficient Device Problem Information1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- No Consequences Or Impact To Patient1
SureSigns VSi models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SureSigns VSi 863276COMPUTER, BLOOD-PRESSURE21 reports
- SureSigns VSi 863275COMPUTER, BLOOD-PRESSURE2 reports
- SureSigns VSi 863277COMPUTER, BLOOD-PRESSURE2 reports
Recent SureSigns VSi adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 23, 2025No Audible Alarm; No Audible Alarm
IT WAS REPORTED THAT THERE WAS A SPEAKER MALFUNCTION MESSAGE, AND NO SOUND COULD BE HEARD. IT IS UNKNOWN IF 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 22311648 ↗MalfunctionDec 21, 2023No Audible Alarm; No Audible Alarm
IT WAS REPORTED THE SURESIGNS VSI NBP/SPO2 MONITOR DID NOT GENERATE ALARMS. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18375122 ↗MalfunctionDec 18, 2023Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE SPO2 MEASUREMENT WAS READING 4 POINTS HIGHER THAN IT ACTUALLY WAS MEASURING. THE DEVICE WAS IN USE. THERE WAS NO PATIENT OR USER HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18346015 ↗MalfunctionOct 25, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback
THE CUSTOMER REPORTED THAT THERE WAS A SPEAKER ERROR WITH NO AUDIO. PATIENT INVOLVEMENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18004596 ↗MalfunctionAug 25, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback
THE CUSTOMER REPORTED THAT THE DEVICE DISPLAYS A MESSAGE INDICATING AUDIO FAILURE AND THERE ARE NO ALARM SOUNDS. THE DEVICE WAS NOT IN USE. THERE WAS NO REPORT OF PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17624279 ↗MalfunctionJan 9, 2023No Audible Alarm; No Audible Alarm
THE CUSTOMER REPORTED THAT A SPEAKER MALFUNCTION INOPS WAS DISPLAYED, NO SOUND WAS COMING FROM THE DEVICE. THE DEVICE WAS IN USE AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED. PHILIPS CONTACTED THE CUSTOMER FOR SERVICE, BUT THE REPAIR WAS REFUSED BY THE CUSTOMER. THE CAUSE REMAINS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16120449 ↗MalfunctionAug 22, 2022No Audible Prompt/Feedback; No Audible Prompt/Feedback
THE CUSTOMER REPORTED THE PROBLEM OF SPEAKER FAILURE ALARM. THE DEVICE WAS NOT IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15270053 ↗MalfunctionAug 11, 2022No Audible Prompt/Feedback; No Audible Prompt/Feedback
THE CUSTOMER ORIGINALLY REPORTED THE PROBLEM OF DEVICE IS NOT WORKING AND REQUESTED A FSE ONSITE FOR FURTHER EVALUATION/TROUBLESHOOTING. UPON INSPECTION OF THE DEVICE, THE FSE OBSERVED THAT THE DEVICE DISPLAYED A "SPEAKER MALFUNCTION". ADDITIONAL INFORMATION RECEIVED FROM THE FSE CONFIRMED THAT, THE DEVICE DISPLAYED SPEAKER MALFUNCTION ERROR AND THERE WAS NO SOUND HEARD. THERE WAS NO REPORTED PATIENT/USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15209767 ↗MalfunctionJul 18, 2022No Audible Prompt/Feedback; No Audible Prompt/Feedback
THE CUSTOMER REQUESTED A LOUDSPEAKER. ADDITIONAL INFORMATION WAS REQUESTED AS TO WHY A LOUDSPEAKER WAS NEEDED, BUT NO RESPONSE WAS RECEIVED. PATIENT INVOLVEMENT IS UNKNOWN. THERE WAS NO REPORTED PATIENT OR USER IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15046255 ↗MalfunctionMar 29, 2022Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED INCONSISTENCIES IN SPO2 READINGS, SOMETIMES THE READINGS ARE HIGH AND SOMETIMES THEY ARE LOW. IT IS UNKNOWN IF THE DEVICE WAS 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 13940112 ↗MalfunctionMar 21, 2022Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE PROBLEM OF INCONSISTENCIES SPO2 READINGS (SOMETIMES HIGH AND SOMETIMES LOW) THERE WAS NO REPORTED PATIENT OR USER IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13839329 ↗MalfunctionFeb 24, 2022Sparking; Sparking
IT WAS REPORTED THAT THE UNIT MADE A BIG FLASH WHILE FSE PERFORMING A SAFETY TEST DURING A ROUTINE SERVICE AND FOUND THE POWER ENTRY MODULE AND POWER CORD ARE BURNT. 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 13595882 ↗MalfunctionJan 28, 2022No Audible Prompt/Feedback; No Audible Prompt/Feedback
THE CUSTOMER REPORTED THE PROBLEM OF SPEAKER FAILURE. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE RELATED TO WHETHER AUDIBLE TONES COULD BE HEARD, BUT NO RESPONSE WAS RECEIVED. IT UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF EVENT, THERE WAS NO REPORTED PATIENT OR USER IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13386281 ↗MalfunctionNov 17, 2021Device Fell; Device Fell
THE CUSTOMER REPORTED THAT IT FELL OFF AND THE TEMPERATURES STOPPED WORKING. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE REPORTED ISSUE WAS DISCOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12829911 ↗MalfunctionNov 8, 2021Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED THE PROBLEM OF SCREEN RECEIVED A SHOCK/IMPACT AND IS BROKEN. PATIENT INVOLVEMENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12771080 ↗
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
- SureSigns VS2+2 models · 56 reports
- Temperature Probes3 models · 1 reports · 1 recall
- PageWriter5 models · 39 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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