Class 2 Device Recall Kodak DirectView DR3000/3500

• Date Initiated by Firm: January 06, 2020
• Create Date: January 13, 2020
• Recall Status: Terminated on May 29, 2020
• Recall Number: Z-0806-2020
• Recall Event ID: 84616
• 510(K)Number: K060550
• Product Classification: System, x-ray, stationary - Product Code KPR
• Product: Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for examination of various anatomical regions. The DR Operator Console is the user interface. All operator functions except positioning the Bucky assembly and controls for the collimator shutter are accomplished at the operator console.
• Code Information: DR3000: 6551360, 6551386, 6551345, 6552160, 6552152, 6551394 DR3500: 6553101, 6553127, 6553119, 6553143, 6553135, 6553036, 6553093
• FEI Number: 1317307
• Recalling Firm/ Manufacturer: Carestream Health, Inc.; 1049 W Ridge Rd; Rochester NY 14615-2731
• For Additional Information Contact: Carestream Customer Care Center; 800-328-2910
• Manufacturer Reason for Recall: Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.
• FDA Determined Cause: Component change control
• Action: On January 6, 2020, the firm distributed Urgent Medical Device Correction letters to affected customers. Users were informed that they may continue to use the system at this time. However, until the correction is executed, Carestream Health strongly recommends against performing any equipment positioning while the patient is near the system to avoid any bodily injury. If the user of the equipment observes any abnormal displacement in the vertical axis during the vertical movement, the device should be removed from use and a service call placed to Carestream (or local dealer) without delay. A Carestream Service Engineer or Carestream Health Authorized Representative will contact user sites and set up a service call to inspect user's devices within the next 6 months to determine whether the inverter parameters are set correctly. If adjustment is needed, the settings will be corrected and proper U-Arm operation will be verified. If you have any questions or concerns, please contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis. Outside of the U.S., please call your local Carestream Service support number. If you have distributed the device outside your facility, please alert your customer(s) of this field correction and contact the Carestream Customer Care Center as instructed above.
• Quantity in Commerce: 79
• Distribution: Worldwide distribution in the sate of Iowa and countries of Italy, China, Spain, and Austria.
• 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