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U.S. Department of Health and Human Services

Class 2 Device Recall Portable HDX Intraoral Dental XRay.

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 Class 2 Device Recall Portable HDX Intraoral Dental XRay.see related information
Date Initiated by FirmMay 16, 2003
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on March 19, 2004
Recall NumberZ-1272-02
Recall Event ID 26413
510(K)NumberK021378 
ProductPortable HDX Intraoral Dental X-Ray. Extraoral Source X-ray System. Part number 300020
Code Information 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 
FEI Number 2520265
Recalling Firm/
Manufacturer		 Den-Tal-Ez Inc,Star Dental Div
1816 Colonial Village Ln
Lancaster PA 17601
For Additional Information ContactKay Engle
717-291-1161 Ext. 4350
Manufacturer Reason
for Recall		problems with product label
FDA Determined
Cause 2		Other
ActionThe recalling firm issued recall letters to the accounts via certified mail on 5/16/03.
Quantity in Commerce231 units
DistributionThe products were shipped to 6 accounts in PA, IL, UT, MD, and NY. Three accounts are government/military locations.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code =
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