Site-Rite 9770177RRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741125362), received between Jun 4, 2018 and Apr 8, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Activation” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2019Unexpected Shutdown

  SALES REP REPORTED: THE SYSTEM SHUTS DOWN MULTIPLE TIMES PER PICC PLACEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8494117 ↗
• MalfunctionSep 28, 2018Reset Problem

  BIOMED REPORTED THAT VISION II TOWER IS FREEZING UP IN SHERLOCK MODE DURING PROCEDURE CAUSING THE USERS TO HAVE TO REBOOT IN THE MIDDLE OF PROCEDURE. THE SYSTEM'S TOUCHSCREEN FUNCTIONS ALSO INTERMITTENTLY SCROLL THROUGH OPTIONS WITHOUT COMMAND. THE TWO REPORTED ISSUES MAY BE RELATED TO THE SAME ROOT CAUSE, ALTHOUGH IT CANNOT YET BE DETERMINED UNTIL EVALUATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7920457 ↗
• MalfunctionSep 7, 2018Loss of Power

  IT WAS REPORTED BY THE PICC TEAM THAT VISION II ULTRASOUND SYSTEM IS SHUTTING DOWN WITHOUT COMMAND EVEN WHILE BEING PLUGGED INTO AC POWER. THE SYSTEM DID SHUT DOWN DURING A PROCEDURE, HOWEVER, THE PICC TEAM WAS ABLE TO REBOOT SYSTEM AND CONTINUE WITH PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7858217 ↗
• MalfunctionJun 4, 2018Difficult or Delayed Activation; Operating System Becomes Nonfunctional

  SR VISION II ULTRASOUND SYSTEM WAS REPORTED TO HAVE AN INTERMITTENT DELAY IN SYSTEM OPERATION AND WOULD OCCASIONALLY FREEZE MID-PROCEDURE. THE BIOMEDICAL ENGINEER WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. FIELD ASSURANCE TECH SUPPORT HAD THE ENGINEER RUN THE SYSTEM DISK OPTIMIZATION AND ADVISED THE ENGINEER TO CONTACT FIELD ASSURANCE IF THE ISSUE PERSISTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7567528 ↗