SureSigns VS4 863283 (UDI 00884838028890)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00884838028890), received between Apr 6, 2017 and May 13, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “No Audible Alarm” (4 reports).

8 FDA recall records name this device's identifier, 8 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. Apr 19, 2019Open, Classified

   System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.

   Z-1318-2019 · Root cause: Software design · FDA record ↗

2. Apr 19, 2019Open, Classified

   System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.

   Z-1320-2019 · Root cause: Software design · FDA record ↗

3. Apr 19, 2019Open, Classified

   System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.

   Z-1317-2019 · Root cause: Software design · FDA record ↗

4. Apr 19, 2019Open, Classified

   System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.

   Z-1321-2019 · Root cause: Software design · FDA record ↗

5. Apr 19, 2019Open, Classified

   System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.

   Z-1319-2019 · Root cause: Software design · FDA record ↗

6. Apr 19, 2019Open, Classified

   System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.

   Z-1324-2019 · Root cause: Software design · FDA record ↗

7. Apr 19, 2019Open, Classified

   System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.

   Z-1323-2019 · Root cause: Software design · FDA record ↗

8. Apr 19, 2019Open, Classified

   System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.

   Z-1322-2019 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  PHILIPS RECEIVED A COMPLAINT ON THE SURESIGNS VS4 NBP, SPO2 INDICATING THE SYSTEM CONTINUOUSLY FREEZES. 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 22011065 ↗
• MalfunctionMar 12, 2024No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THE SPEAKER DOES NOT WORK AND A LOUDSPEAKER ALARM IS TRIGGERED, 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 18886136 ↗
• MalfunctionSep 21, 2020Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE MONITOR FELL FROM THE HOLDER. THE CUSTOMER CONFIRMED THAT THE DEVICE WAS NOT CONNECTED TO A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10560554 ↗
• MalfunctionNov 8, 2019No Audible Alarm

  THE CUSTOMER REPORTED THE PROBLEM OF AFTER REPLACING THE SPEAKER, STILL NO SOUND AND WOULD LIKE TO ORDER MAIN BOARD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9294909 ↗
• MalfunctionMay 29, 2019Protective Measures Problem

  THE CUSTOMER REPORTED THE PROBLEM OF ILLEGAL DOWNLOAD MESSAGE SHOWING ON VS4 UNIT IS FROZEN/NOT IN FRONT OF THE UNIT. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8649310 ↗
• MalfunctionNov 13, 2018Energy Output Problem

  THE CUSTOMER REPORTED A SPEAKER DOES NOT WORK. THE CUSTOMER REPORTED THAT THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE COMPLAINT/EVENT. THERE WAS NO ADVERSE EVENT TO A PATIENT OR USER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8063605 ↗
• MalfunctionOct 12, 2018No Audible Alarm

  THE CUSTOMER REPORTED THAT DEVICE HAS A NO AUDIO/SPEAKER MALFUNCTION. THE CUSTOMER REPORTED THAT IT WAS UNKNOWN AS TO WHETHER THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7960301 ↗
• MalfunctionJul 11, 2017No Audible Alarm

  THE CUSTOMER REPORTED THAT THE DEVICE HAD AN AUDIO FAILURE. THERE WAS NO REPORT OF A DEATH OR SERIOUS INJURY, NOR WAS THERE A REPORT OF ANY ADVERSE IMPACT TO ANY USER OR PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6701026 ↗
• MalfunctionApr 6, 2017Device Operates Differently Than Expected

  THE CUSTOMER STATED THAT THE UNIT IS FREEZING UP. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6464728 ↗