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U.S. Department of Health and Human Services

Class 2 Device Recall Kodak DirectView DR3000/3500

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  Class 2 Device Recall Kodak DirectView DR3000/3500 see related information
Date Initiated by Firm January 06, 2020
Create Date January 13, 2020
Recall Status1 Open3, Classified
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
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 2
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = EASTMAN KODAK COMPANY
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