Events

Recall of Storz Documentation Cart with Articulating Arm, Model Number 9601F

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Karl Storz Endoscopy America 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
    35048
  • Event Risk Class
    Class 2
  • Event Number
    Z-0769-06
  • Event Initiated Date
    2006-03-10
  • Event Date Posted
    2006-04-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45192
  • 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
    unknown device name - Product Code KOG
  • Reason
    The articulating arm on the cart, which holds the monitor, may fall off from the cart during manipulation. when it falls, it could hit the ground or fall on the people/objects that are in close proximity.
  • Action
    Alert letter mailed 03/10/2006 via FedEx to all direct accounts. The firm was instructed to complete the Customer Response Form, which included a box to be checked for who will do the correction (The Customer or The Firm), and fax it back. After the correction is completed, the firm is to fax the Customer Response form a second time completing part 2 of the form.

Device

Storz Documentation Cart with Articulating Arm, Model Number 9601F
  • Model / Serial
    Serial numbers:  82861-8 84504-21 84505-10 84505-30 84987-15  82859-4  82859-5  82859-6  82859-7  82858-8  82858-9  82858-10  81553-1 85358-35 80486C-9 84505-14  82861-1  82861-2  82861-3  82861-4  82861-5 80486C-17 81553-14 81553-20  84987-17  84987-18  84987-19  84987-20  84987-21  84987-22  84987-23  84987-24  84987-34 84987-35 84504-20 84504-24 85358-9 80485-1  80485-2 81552-11 81552-10 81553-19 85358-37 80486C-1 80486C-2 84505-12 82858-4 82858-5 82858-6 82858-7  84987-6  84987-7  84987-8  84987-9  84987-10  84987-11  84504-17  84504-18  84504-19  84505-19  84505-20  84505-21  84505-16  84505-17  84505-18 85358-41 84504-28 82859-3  82859-2  80486C-3  80486C-4  80486C-5  80486C-6 80486C-6  84504-9  84504-10 82861-10  82861-9 81553-6  81553-7 81552-37 81552-19 81552-18  84505-27  84505-28 85358-40 82861-7 82861-6 82860-1  84987-1  84987-2 84505-7 81553-18 81553-18 84987-3 84987-16 84504-26  85358-15  85358-16  85358-17  85358-18  85358-19  85358-20  85358-38  85358-39  85358-1  85358-2  85358-3  85358-4  85358-5  85358-6 80486C-8 85358-21 84505-24 84505-9 81552-14 81552-15 81552-16 80486C-14 81552-17  82860-2  82860-3  82860-4  82860-5  85358-33  85358-34  85358-48  85358-49  85358-50  84505-1  84505-2  84505-3  84505-4  85358-45  85358-46  85358-47 81552-22  81552-23  81552-24  81552-25  81552-26  81552-27  81552-28  81552-29  81552-30  81552-31  81552-32  81552-33  81552-34  81552-35   81553-8  81553-9 81552-4 81552-3 80485-7 82859-1 81553-3 81553-2 80486C-7 81553-10 81552-5 80486C-16 81552-6  80484B-16  80484B-17  80484B-18  80484B-19 80485-3 80485-4 82860-9 82858-1  80484B-6  80484B-7  80484B-8  80484B-9  80484B-10  80484B-11  80484B-12  80484B-13  80484B-14  80484B-15 84957A-1 84957A-3 84957A-5 84957A-4 84957A-7 84957A-2 84957A-6 84504-25  85358-8  85358-9  80486C-11  80486C-12 81553-13  82860-6  82860-7  82860-8 80485-8 80485-9  80485-10 84505-8 80484B-20 81553-4  81553-5 82858-3  85358-26  85358-27  85358-28  85358-29  85358-30  85358-31  85358-32 84987-5 84987-4 81553-15 81553-16 84505-15  85358-10  85358-11  85358-12  85358-13 84504-16  84505-22  84505-23  85358-42  85358-43  85358-44 84504-29 81552-13 80485-5  80485-6  84504-11  84504-12  84504-13  84504-14  84504-15 80486C-19 80486C-20 84505-13 84987-12 84987-28 84987-29 84987-30 84987-31 84987-32 84987-33 84987-3 84987-3 86058-1 86058-2 86058-3 86058-4 86058-5 86058-6 86058-7 86058-8 84987-25 84987-26 84987-27 84987-13 84987-14 86058-11 86058-10 86058-9 86058-12 86058-13 86058-14 86058-15 86747-1 86747-2 86747-3 86747-4 86747-5 86747-6 86747-7 86747-8 86747-9 86747-10 86058-18 86058-17 86747-12 86747-13 86747-14 86747-15 86747-16 86747-11 86747-17 86747-18 86747-29 86747-30 86747-28 86747-21 86747-22 86747-23 86747-24 86747-20 86747-27 86747-31 86747-32 86747-33 86747-34 86747-35 86747-39 86747-38 86747-37 86747-36 86747-49 86747-50 86747-48 86747-46 86747-47 86747-43 86747-44 86747-45 86747-42 86058-2 86058-3 84987-36 84987-37 86058-1 82859-9  82859-10 84504-1  84504-3  84504-4  84504-5  84504-6  84504-7  84504-8  84504-2
  • Distribution
    NATIONWIDE
  • Product Description
    Storz Documentation Cart with Articulating Arm, Model Number 9601F
  • Manufacturer
    Karl Storz Endoscopy America Inc

Manufacturer

Karl Storz Endoscopy America Inc
  • Manufacturer Address
    Karl Storz Endoscopy America Inc, 600 Corporate Pointe, Culver City CA 90230-7600
  • Source
    USFDA