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U.S. Department of Health and Human Services

Class 2 Device Recall Kodak Direct View DR3000 System

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 Class 2 Recall
Kodak Direct View DR3000 System
see related information
Date Posted July 03, 2007
Recall Status1 Terminated on July 02, 2007
Recall Number Z-0717-2007
Recall Event ID 38248
Premarket Notification
510(K) Number
K060550 
Product Classification System, X-Ray, Stationary - Product Code KPR
Product Kodak Direct View DR3000 System, Stationary X-ray System, Catalog #s 655-1345, 655-1386.
Code Information Serial Numbers DR30001001, DR30001004, DR30001006, DR30001014, DR30001016, DR30001017, DR30001020, DR30001021, DR30000032.
Recalling Firm/
Manufacturer
Carestream Health, Inc.
1049 West Ridge Road
Rochester, New York 14615
For Additional Information Contact Ms. Christine E. Ehmann
585-724-4487
Manufacturer Reason
for Recall
The x-ray systems do not indicate the field size when the system's detector is turned off and the collimator is in manual mode. This results in the systems being noncompliant with the field indication performance standards of section 1020.31(e)(2)& (3) of 21Code of Federal Regulations (CFR).
FDA Determined
Cause 2
DESIGN: Labeling Design
Action On 3/06/07, Eastman Kodak notified CDRH of its proposed Corrective Action Plan (CAP). The CAP was approved by CDRH under the following conditions: (1) Kodak will visit each user facility, and apply dial indicator labels to the collimator knobs, apply a field size label to the collimator housing, and verify that each system complies with the field indication performance standard. (2) Kodak will prepare adequate instructions for the assembly/installation and testing of the dial indicators labels and field size labels. These instructions are to be furnished to all owners of the Kodak Direct View DR3000 Systems. (3) Kodak will supplement the Kodak DR3000 system product report with a copy of the adequate instructions. (4) Kodak will perform 100% verification of the recall effectiveness. (5) Kodak will not charge for the corrections and will reimburse the owner for any out-of-pocket expenses. (6) Kodak will notify the manufacturer of the Ralco 302 ACS collimators, Ralco, that the collimator is noncompliant with the performance standard.
Quantity in Commerce Domestic: 7 units, Canada: 2 units
Distribution FL, NY, MO, MI, TX, and Canada
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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