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U.S. Department of Health and Human Services

Class 2 Device Recall Model Kodak 2200 Intraoral XRay System

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  Class 2 Device Recall Model Kodak 2200 Intraoral XRay System see related information
Date Initiated by Firm January 24, 2014
Date Posted March 04, 2014
Recall Status1 Terminated 3 on June 18, 2015
Recall Number Z-1128-2014
Recall Event ID 67349
510(K)Number K060292  
Product Classification Unit, x-ray, extraoral with timer - Product Code EHD
Product Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 5303151, XR-5154323 -- Carestream Health, Inc. Made in France --
--- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major components: x-ray tube, x-ray generator, collimator and image receptor. These systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth, jaw and oral structures.
Code Information Serial Numbers starting with WE, WF, WG, WH, WI, WJ, WK, WL, XA, XB, XC, XD, XE, XF, XG, XH, XI, XJ, XK, XL, YA, YB, YC, YD
Recalling Firm/
Manufacturer		 Carestream Health Inc.
150 Verona St
Rochester NY 14608-1733
For Additional Information Contact Denika Smallwood
800-328-2910
Manufacturer Reason
for Recall		 Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage.
FDA Determined
Cause 2		 Component design/selection
Action Urgent Medical Device Recall Letters (dated 1/24/2014) were sent to the consignees on 1/24/2014 via Certified Mail, Return Receipt Requested.
Quantity in Commerce Domestic: 347 units (total for both)
Distribution Worldwide distribution. USA (nationwide) and the country of Canada.
Total Product Life Cycle TPLC Device Report
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) Database 510(K)s with Product Code = EHD and Original Applicant = KODAK-TROPHY
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