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U.S. Department of Health and Human Services

Class 2 Device Recall KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500

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 Class 2 Recall
KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500
see related information
Date Posted January 27, 2014
Recall Status1 Open
Recall Number Z-0844-2014
Recall Event ID 67188
Premarket Notification
510(K) Number
K051258 
Product Classification System, X-Ray, Stationary - Product Code KPR
Product KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608. Made in U.S.A.
Code Information Service Code: 8087; Catalog numbers: 8791345, 1155118, 1295088, 8551046, 8791345, 1666700, 8531675
Recalling Firm/
Manufacturer
Carestream Health, Inc.
1049 Ridge Rd W
Rochester, New York 14615-2731
Manufacturer Reason
for Recall
Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software due to a possible patient image display error.
FDA Determined
Cause 2
DESIGN: Software Design (Manufacturing Process)
Action On December 26, 2013 Carestream Health, Inc. distributed Urgent Medical Device Recall notification letters dated December 19, 2013 to their customers via Fed Ex. Carestream Health, Inc. recommends that once the daily detector calibration process is initiated on the DR 7500 System running Version 5.X software it should not be interrupted. The calibration process should be completed only when patients are not being imaged. A Carestream Health Service representative will contact all customers to install a software modiciation to Version 5.X software which will not allow the cancellation of detector calibration. Customers will questions can call 1-800-328-2910 7 days per week on a 24 hour basis.
Quantity in Commerce 164 units Total (42 domestically & 122 internationally)
Distribution Domestic: IN, PA, MD, MI, NY, GA, MN, OK, VA, TX, WI, CA, IL, TN, WA, NC, SC, MA, NJ, and KY; Foreign: Canada, New Zealand, South Korea, Australia, Hong Kong, Saudia Arabia, Guinea, Kuwait, Israel, Oman, South Africa, China, UK, Sweden, Poland, Denmark, Germany, Finland, Czech Republic, Italy, France, Portugal and Spain.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = EASTMAN KODAK COMPANY
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