Class 2 Device Recall Kodak Direct View DR3000 System

• Date Initiated by Firm: March 06, 2007
• Date Posted: July 03, 2007
• Recall Status: Terminated on July 02, 2007
• Recall Number: Z-0717-2007
• Recall Event ID: 38248
• 510(K)Number: K060550
• Product Classification: X Ray System - 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 NY 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: Other
• 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 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 = KPR