Events

Recall of Device Recall Tube Stand for the Dynarad Phantom Portable XRay System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Del Medical Systems Group.

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
    31456
  • Event Risk Class
    Class 2
  • Event Number
    Z-0816-05
  • Event Initiated Date
    2005-03-10
  • Event Date Posted
    2005-05-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37928
  • 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
    Tube Mount, X-Ray, Diagnostic - Product Code IYB
  • Reason
    The phantom portable x-ray system stand may have a suspect weld supporting the bracket holding the locking cylinder assembly. it the weld fails, the tubehead arm assembly could fall and contact the patient or operator.
  • Action
    Del Medical sent Field Correction Recall letters dated 3/10/05 to the direct accounts, informing them of the potential for a defective weld supporting the braket holding the locking cylinder assembly. If the weld fails, the tubehead arm assembly could potentially fall and contact the patient or operator. The accounts were requested to locate the affected systems and take them out of service until they are inspected and, if needed, repaired.

Device

Device Recall Tube Stand for the Dynarad Phantom Portable XRay System
  • Model / Serial
    All Phantom Model Tube Stands with squared corners on all four corners of the stand. Catalog #501031, serial numbers 00743-0204, 00778-0204, 00997-0304, 01001-0304, 01103-0304, 01293-0304, 01371-0304, 01425-0404, 01452-0404, 01470-0404, 01475-0404, 01575-0404, 01592-0404, 01700-0404, 01704-0404, 01790-0404, 01841-0404, 01851-0404, 01898-0504, 02019-0504, 02023-0504, 02051-0504, 02096-0504, 02178-0504, 02188-0504, 02310-0604, 02357-0604, 02429-0604, 02517-0604, 02534-0604, 02584-0604, 02671-0604, 02752-0704, 02760-0704, 02776-0704, 02839-0704, 02891-0704, 02928-0704, 02938-0704, 02945-0704, 02959-0704, 02980-0704, 02991-0704, 03076-0704, 03084-0704, 03122-0704, 03375-0804, 03455-0804, 03476-0804, 03518-0804, 03543-0804, 03570-0904, 03579-0904, 03636-0904, 03700-0904, 03708-0904, 03722-0904, 03740-0904, 03952-0904, 04037-0904, 04134-1004, 04183-1004, 04347-1004, 04380-1004, 04407-1004, 04477-1004, 04481-1004, 04491-1004, 04524-1004, 04534-1004, 04592-1104, 04600-1104, 04605-1104, 04648-1104, 04694-1104, 04699-1104, 04703-1104, 0439-1104, 04783-1104, 04862-1104, 05190-1204, 05194-1204, 05198-1204, 05216-1204, 05364-1204, 05414-1204, 05418-1204, 05439-1204, 00283-0105, 00340-0105, 00481-0105, 00571-0205, 00575-0205, 00617-0205, 00649-0205, 00763-0205, 00841-0205, 00858-0205, 00891-0205, 00900-0205, 00913-0205
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, Mexico and Thailand.
  • Product Description
    Tube Stand for the Dynarad Phantom Mobile X-Ray System; Del Medical Systems, 11550 West King Street, Franklin Park, IL 60131
  • Manufacturer
    Del Medical Systems Group

Manufacturer

Del Medical Systems Group
  • Manufacturer Address
    Del Medical Systems Group, 11550 West King Street, Franklin Park IL 60131-1330
  • Source
    USFDA