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U.S. Department of Health and Human Services

Class 2 Device Recall KODAK DirectView DR 9000 System

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  Class 2 Device Recall KODAK DirectView DR 9000 System see related information
Date Initiated by Firm May 30, 2014
Date Posted August 01, 2014
Recall Status1 Terminated 3 on December 17, 2014
Recall Number Z-2137-2014
Recall Event ID 68406
Product Classification System, x-ray, stationary - Product Code KPR
Product KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installed diagnostic x-ray system composed of 3 main components: an operator console, U-Arm assembly with x-ray tube including a collimator, and a stationary generator.
Code Information Service Code 1534
Recalling Firm/
Manufacturer		 Carestream Health Inc.
150 Verona St
Rochester NY 14608-1733
For Additional Information Contact
800-328-2910
Manufacturer Reason
for Recall		 A control system failure may cause the U-Arm to move downward unexpectedly when the Radiology Technologist is positioning the equipment using the "Up" or "Down" control buttons. Downward movement occurs at three times the normal rate of speed and will continue until the device control button is released, the Emergency Stop button is activated or the equipment Bump Sensor contacts an object.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Urgent Medical Device Recall Letters (dated 5/29/2014) were sent to the consignees on 5/30/2014. Carestream Health recommends that the DR 9000 U-arm be moved before positioning the patient under the U-arm for a decubitus exam. This will remove any potential safety hazard posed to the patient as a result of any unexpected movement. For questions or concerns, please contact the Carestream Customer Care Center in the US at 1-800-328-2910, available 7 days per week on a 24 hour basis; Outside of the US, please call your local Service support number.
Quantity in Commerce Domestic: 100 units; Foreign: 46 units
Distribution Worldwide Distribution-USA (nationwide) and the countries of Canada, China, Italy, Germany, Greece, Kuwait, Spain, South Africa, and United Arab Emirates.
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.
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