Events

Recall of Sierra Scientific Motility Visualization System (MVS)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sierra Scientific Instruments Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60175
  • Event Risk Class
    Class 2
  • Event Number
    Z-0135-2012
  • Event Initiated Date
    2011-10-12
  • Event Date Posted
    2011-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104678
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, gastrointestinal motility (electrical) - Product Code FFX
  • Reason
    The recall was initiated after given imaging received a test report during a canadian licensing process where the ar manoshield exhibited pinholes and did not pass the test, the field safety corrective action (fsca) committee was convened. as a result of the data discussed during this meeting, a decision was made to voluntarily recall this product, and cease its further commercialization or distr.
  • Action
    Given Imaging sent an "Urgent Product Recall 1st Notice" letter with an attached Device Recall Confirmation Form (via Fed Ex with signature for tracking purposes) to all customers who purchased the AR ManoShield, part numbers MSS-3599. The letter provides the customers with an explanation of the problem identified and actions to be taken. Customers were instructed to locate the affected product and removed from use immediately. The letter stated that if the affected product have been further distributed, forward this letter immediately to all customers who received the affected product. Customers were asked to complete and return the enclosed confirmation form as per the instructions. Customers with any questions were instructed to contact Karla Guerrero at (310) 641-8492 ext. 2138 or email at karla.guerrero@givenimaging.com.

Device

Sierra Scientific Motility Visualization System (MVS)
  • Model / Serial
    F1112702UA, F1113101UA, F1113103UA, F1113104UA, F1113401UA, F1114201UA, F1114617UA, F1114618UA, F1114619UA, F1114620UA, F1114621UA, F1114623UA, F1114624UA, F1114625UA, F1114626UA, F1114627UA, F1114628UA, F1114629UA, F1115402UA, F1116306UA, F1117207UA, F1119201UA, F1119401UA, F1121304UA, F1123201UA, F1123405UA, F1123703UA, F1124202UA, F1124301UA, F1125105UA, F1125201UA, F1127303UA, F1128101UA, F1129701UA, F1130202UA, F1130304UA, F1128301UA, F1127103UA, F1127205UA,
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of: Austria, Belgium, Canada, Chile, China, Columbia, Ecuador, France, Germany, Israel, Mexico, Poland, Portugal, Sweden, and Switzerland.
  • Product Description
    AR ManoShield, MSS-3599, 10 pack. || FGS: MSS-3599, || Individual package label: LBL-110275-03, || Box label: LBL-110282-03, || Package Inserts: DOC-3682, || User Manual: DOC-1332-12. || Product Usage: The MVS disposable sheath (a.k.a. ManoShield) for the high-resolution MVS catheter is designed to provide a biocompatible barrier between the catheter and patient.
  • Manufacturer
    Sierra Scientific Instruments Inc

Manufacturer

Sierra Scientific Instruments Inc
  • Manufacturer Address
    Sierra Scientific Instruments Inc, 5757 W Century Blvd Ste 660, Los Angeles CA 90045-6456
  • Source
    USFDA