Events

Recall of Device Recall Portable HDX Intraoral Dental XRay.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Den-Tal-Ez Inc,Star Dental Div.

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
    26413
  • Event Risk Class
    Class 2
  • Event Number
    Z-1272-02
  • Event Initiated Date
    2003-05-16
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-03-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27638
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • Reason
    Problems with product label.
  • Action
    The recalling firm issued recall letters to the accounts via certified mail on 5/16/03.

Device

Device Recall Portable HDX Intraoral Dental XRay.
  • Model / Serial
    Lot number 765370 - Serial Number XR0007058 Lot number 779057 - Serial Numbers XR0006002 through XR0006017 Lot number 790256 - Serial Numbers XR0006018 through XR0006032 Lot number 793359 - Serial Numbers XR0006033 through XR0006039; XR0006042 through XR0006050 Lot number 802157 - Serial Numbers XR0006056 through XR0006061 Lot number 806758 - Serial Numbers XR0007001 through XR0007006 Lot number 808557 - Serial Numbers XR0007007 through XR0007014; XR0007018 through XR0007019; XR0007021 through XR0007022 Lot number 812560 - Serial Numbers XR0007023 through XR0007034 Lot number 815057 - Serial Numbers XR0007035 through XR0007046 Lot number 819457 - Serial Numbers XR0007053 through XR0007057; XR0007059 through XR0007064; XR0007070 Lot number 828262 - Serial Numbers XR0007071 through XR0007081; XR0008001 through XR0008014 Lot number 843969 - Serial Numbers XR0008015 through XR0008022; XR0008025 through XR0008034; XR0008037 through XR0008038; XR0008058 through XR0008062 Lot number 854056 - Serial Numbers XR0008039 through XR0008046; XR0008048 through XR0008057; XR0008063 through XR0008064 Lot number 858667 - Serial Numbers XR0008065 through XR0008077 Lot number 886858 - Serial Numbers XR0009033 and XR0010041 Lot number 991168 - Serial Number XR0107030 Lot number 1116310 - Serial Numbers XR0108024; XR0107026 through XR0107029; XR0107036 through XR0107065 Lot number 1241582 - Serial Numbers XR0203022 through XR0203023 Lot number SHOW UNIT ¿ Serial Number XR0107066
  • Product Classification
    Radiology Devices
  • Distribution
    The products were shipped to 6 accounts in PA, IL, UT, MD, and NY. Three accounts are government/military locations.
  • Product Description
    Portable HDX Intraoral Dental X-Ray. Extraoral Source X-ray System. Part number 300020
  • Manufacturer
    Den-Tal-Ez Inc,Star Dental Div

Manufacturer

Den-Tal-Ez Inc,Star Dental Div
  • Manufacturer Address
    Den-Tal-Ez Inc,Star Dental Div, 1816 Colonial Village Ln, Lancaster PA 17601
  • Source
    USFDA