Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall INSIGHT Dental Film

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 3 Device Recall INSIGHT Dental Filmsee related information
Date Initiated by FirmJuly 02, 2014
Date PostedAugust 01, 2014
Recall Status1 Terminated 3 on May 25, 2016
Recall NumberZ-2142-2014
Recall Event ID 68647
Product Classification Film, radiographic - Product Code IWZ
ProductINSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
Code Information Lot Numbers: 53901201, 53801303, 53801303-1, 54601201, 54601201-1   
Recalling Firm/
Manufacturer		 Carestream Health Inc.
150 Verona St
Rochester NY 14608-1733
For Additional Information ContactKarla Fossoy
800-328-2910
Manufacturer Reason
for Recall		The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental intraoral film. This may cause confusion for the dental practitioner. If the processed film is placed on the view box by referencing the film's raised dot, the image orientation will be rotated 180 degrees.
FDA Determined
Cause 2		Package design/selection
ActionRecall notices were mailed to US Customers via overnight carrier on 07/02/2014. Customers are asked to complete an inventory of goods to be returned which will be ultimately destroyed by recalling company. If you have any questions or concerns, please contact the Carestream Customer Care Center in the U.S. at 1-800-933-8031.
Quantity in Commerce1633 boxes
DistributionWorldwide Distribution.
Total Product Life CycleTPLC 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.
-
-