Events

Recall of HCMI operator control panels for chiropractic x-ray systems, Model #HF300, HF600, HF3SE, and HF3SEE.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Health Care Manufacturing 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
    27108
  • Event Risk Class
    Class 2
  • Event Number
    Z-0729-03
  • Event Initiated Date
    2003-05-15
  • Event Date Posted
    2003-12-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-11-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29207
  • 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, X-Ray, Stationary - Product Code KPR
  • Reason
    Required labeling (certification and manufacturer's label) was missing from the operator control panels.
  • Action
    The firm initiated recall with telephone calls approximately 5/15/03 requesting the dealers to provide customer names so they could send corrective labels directly to the users.

Device

HCMI operator control panels for chiropractic x-ray systems, Model #HF300, HF600, HF3SE, and HF3...
  • Model / Serial
    Serial numbers 108, 111, 140, 153, 160, 180, 214, 217, 238, 242, 246, 247, 251 thru 254, 256 thru 267, 269 thru 272, 275, 276, 279, 280, 283, 284, 287, 288, 289, 302 thru 318, 321, 322, 323, 330 thru 334, 352, and 1001 thru 1407.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution was made to dealers located nationwide.
  • Product Description
    HCMI operator control panels for chiropractic x-ray systems, Model #HF300, HF600, HF3SE, and HF3SEE.
  • Manufacturer
    Health Care Manufacturing Inc

Manufacturer

Health Care Manufacturing Inc
  • Manufacturer Address
    Health Care Manufacturing Inc, 2146 East Pythian, Springfield MO 65802
  • Source
    USFDA