Events

Recall of Device Recall Del Medical VS300 radiographic Cassette Holder or Wall Stand

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Del Medical, 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
    72798
  • Event Risk Class
    Class 2
  • Event Number
    Z-0762-2016
  • Event Initiated Date
    2015-12-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-01-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142238
  • 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
    Holder, radiographic cassette, wall-mounted - Product Code IXY
  • Reason
    The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient.
  • Action
    The firm sent an email followed by a certified undated letter entitled Safety Related Notification- Field Corrective Action VS-200 and VS-300 Wallstands notifying customers of the recall and actions to be taken. To prevent the possible interruption of service, Del Medical has prepared a service kit which must be installed at the next available opportunity. Del Medical is sending service kits to affected customers. Included within the package will be needed components and, a fixture which will facilitate a one person job. The firm expects the procedure to occupy one hour or, less. Also included with each kit will be an acknowledgement form which is intended to document the fix. The form, along with the original parts are to be returned to Del Medical upon completion of the activity to the following address: Del Medical 241 Covington Drive Bloomingdale, Illinois 60108 Attention: Bill Kostecki 1-847-288-7000

Device

Device Recall Del Medical VS300 radiographic Cassette Holder or Wall Stand
  • Model / Serial
    Product # Serial # 110-5124G1 , 00019-0114 110-5124G1 , 00020-0114 110-5124G1 , 00092-0114 110-5124G1 , 00551-0314 110-5124G1 , 00512-0214 110-5124G1 , 00447-0214 110-5124G1 , 00016-0114 110-5124G1 , 00554-0314 110-5124G1 , 00094-0114 110-5124G1 , 00256-0214 110-5124G1 , 00741-0314 110-5124G1 , 00446-0214 110-5124G1 , 00017-0114 110-5124G1 , 00093-0114 110-5124G1 , 00236-0114 110-5124G1 , 00814-0414 110-5124G1 , 00815-0414 110-5124G1 , 00340-0214 110-5124G3 , 00995-0414 110-5124G1 , 00338-0214 110-5124G1 , 00552-0314 110-5124G1 , 00253-0214 110-5124G1 , 00445-0214 110-5124G1 , 00254-0214 110-5124G1 , 00095-0114 110-5124G1 , 00670-0314 110-5124G1 , 00252-0214 110-5124G1 , 00018-0114 110-5124G1 , 00669-0314 110-5124G1 , 00339-0214 110-5124G1 , 00444-0214 110-5124G1 , 00255-0214
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) and the countries of Canada, Costa Rica, Libya, Mexico, and Philippines.
  • Product Description
    VS300 radiographic Cassette Holder or Wall Stand. For use in radiology department.
  • Manufacturer
    Del Medical, Inc.

Manufacturer

Del Medical, Inc.
  • Manufacturer Address
    Del Medical, Inc., 241 Covington Dr, Bloomingdale IL 60108-3109
  • Manufacturer Parent Company (2017)
    Del Medical Inc.
  • Source
    USFDA