Medex MX960Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10351688502988), received between Jan 6, 2022 and Jun 6, 2024 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Unable to Obtain Readings” (4 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE BUTTON COULDN¿T BE PRESSED PROPERLY. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19477686 ↗
• MalfunctionJun 6, 2024Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT THE 100MMHG TEST FAILS, 100MMHG±3 IS SPECIFIED, AND THE ACTUAL MEASURED VALUE REACHES 1000MMHG. DEVICE DID NOT PASS THE PRESSURE VALUE TEST, THERE WAS A DISCREPANCY. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19477551 ↗
• MalfunctionApr 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AFTER ZEROING, THE PRESSURE VALUE IS NOT DISPLAYED WHEN PRESSED. THE PRESSURE VALUE IS ZERO. THE EVENT OCCURRED DURING SET UP. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19119547 ↗
• MalfunctionApr 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Failure to Zero; Connection Problem; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Zero; Connection Problem

  IT WAS REPORTED THAT THE "PRESSURE PLATE ZERO IS NOT WITHIN 100±3. THE P1 P2 P3 P4 VALUE SHOWS 196-197. THE PORT IS NOT IN GOOD CONTACT AND CANNOT BE CONNECTED. THE PRESSURE VALUE IS DISPLAYED AS 1067-1066; WHICH IS MARKED AS 100±3." THERE WAS NO PATIENT INVOLVEMENT REPORTED AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19119270 ↗
• MalfunctionMar 19, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT IT HAS A FAULTY CONNECTOR, THE PRESSURE WAVE VARIES WHEN CABLE PLUG IS FLEXED. THE REPORTED PRODUCT FAULT WAS DETECTED DURING INITIAL EQUIPMENT CHECKS PRIOR TO CLINIC STARTING. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18937494 ↗
• MalfunctionJan 23, 2024Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT THE PRESSURE SENSOR DID NOT RESPOND AFTER BEING CONNECTING TO THE SENSOR BOARD AND THE PRESSURE VALUE COULD NOT BE DETECTED. AFTER REPLACING THE PRESSURE SENSOR BOARD WITH A NEW ONE, THE DISPLAY APPEARED. THIS REPORTEDLY OCCURRED WITH 43 PRESSURE SENSORS. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18563132 ↗
• MalfunctionMay 8, 2023No Pressure; No Pressure

  IT WAS REPORTED THAT THE HOSPITAL STARTED USING THE PRODUCT ON APRIL 5TH AND ON JUNE 7TH THE PRODUCT STOPPED DETECTING BLOOD PRESSURE. PRODUCT WAS SWITCHED OUT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16885241 ↗
• MalfunctionMay 5, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE CUSTOMER CANNOT RETURN TO ZERO, EXCESSIVE DRIFT, AND CANNOT READ DATA. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16875660 ↗
• MalfunctionMay 4, 2023Display Difficult to Read; Mechanical Problem; Display Difficult to Read; Mechanical Problem

  IT WAS REPORTED THAT THE DEVICE WOULD NOT RETURN TO ZERO, EXCESSIVE DRIFT, AND UNABLE TO READ DATA. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16872996 ↗
• MalfunctionMay 3, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE DEVICE CANNOT RETURN TO ZERO, HAS EXCESSIVE DRIFT AND CAN NOT READ DATA. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16865980 ↗
• MalfunctionMay 2, 2023Explosion; Explosion

  IT WAS REPORTED THAT THE DEVICE EXPLODED DURING THE PROCEDURE. THIS LED TO THE PATIENTS BLOOD PRESSURE NOT BEING ABLE TO BE CHECKED AT THE BEGINNING OF THE EXAMINATION. A DIFFERENT TRANSDUCER WAS USED TO BE ABLE TO MONITOR THE PATIENT AND GET THEM HEMODYNAMICALLY STABLE. NO HARM TO THE PATIENT CAME FROM THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16857165 ↗
• MalfunctionOct 26, 2022Device Difficult to Program or Calibrate; Failure to Calibrate; Calibration Problem; Device Difficult to Program or Calibrate; Failure to Calibrate; Calibration Problem

  IT WAS REPORTED THAT THE ZERO POINT CALIBRATION COULD NOT BE PERFORMED. WHILE PRESSING THE ZERO CALIBRATION BUTTON ON THE POLYGRAPH, THE WAVEFORM DID NOT BECOME FLAT AND COULD NOT BE CALIBRATED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15674488 ↗
• MalfunctionSep 16, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PRESSURE TRANSDUCER READINGS HAD A CONSTANT DRIFT DURING USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15439296 ↗
• MalfunctionSep 9, 2022Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT THE PRESSURE TRANSDUCER READINGS HAD A CONSTANT DRIFT DURING USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15391959 ↗
• MalfunctionJan 31, 2022Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THERE FOUR DEVICES HAVE NO DATA TO READ. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13392419 ↗
• MalfunctionJan 28, 2022Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THERE FOUR DEVICES HAVE NO DATA TO READ. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13386311 ↗
• MalfunctionJan 27, 2022Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THERE FOUR DEVICES HAVE NO DATA TO READ. NO ADDITIONAL INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13369849 ↗
• MalfunctionJan 27, 2022Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THERE FOUR DEVICES HAVE NO DATA TO READ. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13369412 ↗
• MalfunctionJan 27, 2022Inappropriate Waveform; Inappropriate Waveform

  IT WAS REPORTED THAT NO WAVEFORMS WERE SHOWING. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13367668 ↗
• MalfunctionJan 27, 2022Inappropriate Waveform; Inappropriate Waveform

  IT WAS REPORTED THAT NO WAVEFORMS WERE SHOWING. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13367605 ↗
• MalfunctionJan 6, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE DATA CANNOT BE READ OUT DURING USE, OR THERE IS EXCESSIVE OFFSET, WHICH MAKES IT UNUSABLE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13176528 ↗