Events

Recall of Device Recall Richard Wolf Medical Instrument Corp. ICart

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Richard Wolf Medical Instruments Corp..

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
    70220
  • Event Risk Class
    Class 2
  • Event Number
    Z-1240-2015
  • Event Initiated Date
    2014-12-10
  • Event Date Posted
    2015-03-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133375
  • 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
    Monitor, bed patient - Product Code KMI
  • Reason
    The transformers installed on carts used for richard wolf medical video systems may overheat causing smoke and black plastic material to leak from the cart chassis.
  • Action
    Field Action Notice letters dated December 10, 2014 were sent to both direct accounts (customers). The letters instructed customers to: 1) Instruct the biomed to bypass the integrated power grid on the cart and not to use the electrical system on the affected carts until a qualified Omni Corporation service technician is able to inspect and repair the carts; and 2) Omni Corporation will schedule a qualified Omni field service technician, in conjunction with Richard Wolf and the customer's biomed unit, to visit and replace the transformer on the cart.

Device

Device Recall Richard Wolf Medical Instrument Corp. ICart
  • Model / Serial
    (NOTE: The listed serial numbers are for the carts manufactured and include those that were distributed.)   1) Part Number: 31113.801; Serial Numbers: 1306000, 1306007, 1306014, 1306021, 1306103, 1306001, 1306008, 1306015, 1306022, 1306104, 1306002, 1306009, 1306016, 1306023, 1306105, 1306003, 1306010, 1306017, 1306024, 1307100, 1306004, 1306011, 1306018, 1306100,  1307101, 1306005, 1306012, 1306019, 1306101, 1307102, 1306006, 1306013, 1306020, 1306102, 1317103.   2) Part Number: 31113.701; Serial Numbers: 11001, 11011, 11020, 11030, 11039, 11048, 11058, 11002, 11012, 11021, 11031, 11040, 11049, 11059, 11003, 11013, 11023, 11032, 11041, 11050, 11060, 11005, 11014, 11024, 11033, 11042, 11051, 11061, 11006, 11015, 11025, 11034, 11043, 11052, 11063, 11007, 11016, 11026, 11035, 11044, 11053, 11064, 11008, 11017, 11027, 11036, 11045, 11055, 11065, 11009, 11018, 11028, 11037, 11046, 11056, 11066, 11010, 11019, 11029, 11038, 11047, 11057, 11067.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    The I-Cart is used to store, transport, and power video equipment used in medical procedures.
  • Manufacturer
    Richard Wolf Medical Instruments Corp.

Manufacturer

Richard Wolf Medical Instruments Corp.
  • Manufacturer Address
    Richard Wolf Medical Instruments Corp., 353 Corporate Woods Pkwy, Vernon Hills IL 60061-3110
  • Manufacturer Parent Company (2017)
    Richard Und Annemarie Wolf Stiftung
  • Source
    USFDA