FDA Medical Device Recalls (openFDA)
Den-Tal-Ez Inc,Star Dental Div: Portable HDX Intraoral Dental X-Ray. Extraoral Source X-ray System. Part number 300020
- Recall number
- Z-1272-02
- Recalling firm
- Den-Tal-Ez Inc,Star Dental Div
- Product
- Portable HDX Intraoral Dental X-Ray. Extraoral Source X-ray System. Part number 300020
- Status
- Terminated
- Initiated
- 2003-05-16
- Posted
- 2004-07-20
- Terminated
- 2004-03-19
- Reason
- problems with product label
- Root cause
- Other
- Action
- The recalling firm issued recall letters to the accounts via certified mail on 5/16/03.
- Quantity
- 231 units
- Distribution
- The products were shipped to 6 accounts in PA, IL, UT, MD, and NY. Three accounts are government/military locations.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K021378"]
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 2520265
- Firm city
- Lancaster
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28