BD SiteRite 9 Ultrasound System 9770800Recalls & reported problems

Summary

The FDA's MAUDE database contains 172 adverse event reports that list this exact device (DI 00801741226243), received between Dec 5, 2023 and Sep 30, 2026 — classified as 172 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (74 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 172 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Difficult or Delayed Activation

  It was reported unit has a 1 second delayed image. No patient impact. Out of box failure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941956 ↗
• MalfunctionSep 30, 2026No Display/Image

  It was reported unable to find the needle tip during midline placement. No patient impact. No further information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941798 ↗
• MalfunctionSep 23, 2026Data Problem

  It was reported the 3CG feature is showing internal reading before inserting the PICC. No patient impact. No further information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870560 ↗
• MalfunctionSep 22, 2026Data Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853502 ↗
• MalfunctionJun 4, 2026Difficult or Delayed Activation

  IT WAS REPORTED THAT USERS ARE COMPLAINING OF LAGGING. SOFTWARE IS UP TO DATE. CUE IS NOT BEING USED AND HAS BEEN TURNED OFF. UNIT WAS JUST IN TO REPAIR USB PORTS. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25402573 ↗
• MalfunctionMay 12, 2026Poor Quality Image

  IT WAS REPORTED BY A TM- IMAGE IS "FUZZY" AND JUMPY, SEEMS TO HAVE A SHADOW. WITH PROBE COVER (ANY PROBE COVER) THE IMAGE BECOMES MORE DISTORTED, CANNOT VISUALIZE NEEDLE TIP. LOOSE CONNECTION TO IPAD. I BELIEVE THEY WERE REFERENCING THE USB CONNECTION FROM THE SHERLOCK TO THE ULTRASOUND MACHINE. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25155995 ↗
• MalfunctionMay 4, 2026Difficult or Delayed Activation

  IT WAS REPORTED THAT UNIT HAVING SIGNIFICANT LAG ISSUES WHILE SCANNING. NO ADDITIONAL DETAILS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25070013 ↗
• MalfunctionApr 13, 2026Unexpected Shutdown

  IT WAS REPORTED THAT SHUTS DOWN AND DUMPS PHOTOS AT LEAST 1-2 TIMES PER DAY. HOLDS BATTERY BETTER IF PUT TO SLEEP RIGHT AFTER YOU USE IT, BUT IT DOESN'T NECESSARILY SHUT DOWN. NOT TURNING ON LESS OFTEN. EVERY OTHER OR THIRD DAY. NO FURTHER DETAILS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24861042 ↗
• MalfunctionApr 13, 2026Unexpected Shutdown

  IT WAS REPORTED THAT SHUTS DOWN AND DUMPS PHOTOS AT LEAST 1-2 TIMES PER DAY. HOLDS BATTERY BETTER IF PUT TO SLEEP RIGHT AFTER YOU USE IT, BUT IT DOESN'T NECESSARILY SHUT DOWN. NOT TURNING ON LESS OFTEN. EVERY OTHER OR THIRD DAY. NO FURTHER DETAILS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24860459 ↗
• MalfunctionMar 25, 2026No Apparent Adverse Event; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT FLASHING LINES, FREEZING UP DURING USE. TM EMAILED BACK ON 3/11/2026 ADVISING THE UNIT IS ALSO GIVING 3 NEW ERRORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689502 ↗
• MalfunctionMar 23, 2026Data Problem

  IT WAS REPORTED SENSOR IS INTERMITTENTLY LOSING CONNECTION/NOT GIVING CORRECT READING LOCATIONS FOR TIP CONFIRMATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24666996 ↗
• MalfunctionFeb 18, 2026Application Program Freezes or Fails to Launch

  IT WAS REPORTED UNIT HAS FROZEN A FEW TIMES AND IS SUPER SLOW TO SEND RECORDS. UNIT ALSO GAVE EC112. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384168 ↗
• MalfunctionFeb 18, 2026Data Problem

  IT WAS REPORTED BY A BIOMEDICAL ENGINEER THAT THEY ARE GETTING INACCURATE READINGS WHEN USING THE SENSOR. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384166 ↗
• MalfunctionFeb 3, 2026Data Problem

  IT WAS REPORTED, SHERLOCK IS NOT BEING PICKED UP CONSISTENTLY AND WILL DISAPPEAR FREQUENTLY, OFTEN FOR MORE THAN A MINUTE AT A TIME. ALSO LARGE DISCREPANCY WHEN GETTING NEGATIVE P-WAVE ON 3CG, WITH A VARIANCE OF UP TO 5 CM LEADING TO UNRELIABLE READINGS AND HAVING TO GET PATIENT CHEST X-RAY TO CONFIRM PLACEMENT. VAT ARE EXPERIENCED AND HAVE USED SR8 AND 9 FOR YEARS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251517 ↗
• MalfunctionFeb 3, 2026Poor Quality Image

  IT WAS REPORTED, IMAGE QUALITY ISSUES WITH THEIR SR9 AND PROBE. THEY'VE HAD THE UNIT COME IN ONCE BEFORE BUT THEY COULDN'T CONFIRM THE ISSUE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251490 ↗
• MalfunctionJan 27, 2026Application Program Freezes or Fails to Launch

  IT WAS REPORTED, CUSTOMER'S SITE RITE 9 CONTINUED TO FREEZE TO THE POINT OF NEEDING TO REMOVE THE BATTERY EVERY TIME FOR IT TO UNFREEZE. THE CUSTOMER DID NOT REPORT A SPECIFIC NUMBER OF TIMES THE UNIT FROZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24193758 ↗
• MalfunctionJan 23, 2026Data Problem

  IT WAS REPORTED BY THE CUSTOMER THEY ARE HAVING ISSUES WHEN USING A SHERLOCK SENSOR, AT TIMES GETTING INACCURATE READINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24162784 ↗
• MalfunctionDec 22, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE UNIT SHUTS OFF WHEN POWER ADAPTER IS DISCONNECTED FROM SR9. VERIFIED BATTERY HAS BEEN RESEATED WITH SAME RESULT. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864850 ↗
• MalfunctionDec 10, 2025Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event

  IT WAS REPORTED THAT THE IMAGE IS BLURRED OUT AND HALF THE SCREEN IS BLACK. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771992 ↗
• MalfunctionDec 9, 2025Data Problem; Data Problem

  IT WAS REPORTED THAT THE TIP TRACING IS DELAYED DURING PLACEMENT. THE MACHINE DELAY MAY HAVE CAUSED THE TIP OF THE PICC TO BE 7CM TOO DEEP. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23763965 ↗
• MalfunctionDec 3, 2025No Display/Image; Unexpected Shutdown; No Display/Image; Unexpected Shutdown

  IT WAS REPORTED BY A TM THAT THE SCREEN RANDOMLY GOES BLANK. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707191 ↗
• MalfunctionDec 2, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THE DEVICE WAS CHARGED AND PLUGGED IN WHEN THE SCREEN TURN BLACK AND COMPLETELY STOPPED WORKING/RESPONDING. THE BUTTON ON THE RIGHT WAS LIT UP BUT EVERYTHING ELSE WAS BLACK AND UNRESPONSIVE. COULD NOT DO A MANUAL SHUT DOWN AND TAKING THE BATTERY OUT DID NOT WORK. AFTER LETTING THE UNIT DIE AND PLUGGING IT BACK IN IT SEEMED TO BE WORKING NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696423 ↗
• MalfunctionNov 20, 2025Poor Quality Image; Poor Quality Image

  IT WAS REPORTED GETTING INTERFERENCE, DISTORTED IMAGE WHEN TRYING TO SET NEEDLE. THEY HAVE TRIED MULTIPLE PROBES AND THEY ARE GETTING THE SAME RESULTS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610426 ↗
• MalfunctionNov 11, 2025Poor Quality Image; Poor Quality Image

  IT WAS REPORTED OF ISSUES WITH IMAGE QUALITY AND NO MATTER WHAT PROBE THEY ARE USING. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526409 ↗
• MalfunctionOct 30, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE UNIT IS HAVING ISSUES WITH THE BATTERY, IT SHOWED IT WAS AT 70% AND THEN TURNED OFF. SO FAR IT HAS HAPPENED A FEW TIMES NOW. THE EXACT NUMBER OF OCCURRENCES WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425725 ↗