Class 2 Device Recall CARESTREAM DIRECTVIEW CR

• Date Initiated by Firm: October 30, 2014
• Date Posted: December 17, 2014
• Recall Status: Terminated on March 10, 2017
• Recall Number: Z-0820-2015
• Recall Event ID: 69703
• 510(K)Number: K020635 K923554
• PMA Number: P080018
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
• Code Information: Software Verions: 1) 5.7.312.27 , 2) 5.7.312.27, 3) 5.7.312.2031
• Recalling Firm/ Manufacturer: Carestream Health, Inc.; 1049 W Ridge Rd; Rochester NY 14615-2731
• For Additional Information Contact: 585-781-1997
• Manufacturer Reason for Recall: Reduced mammographic image quality when attempting to print true size multi-format images
• FDA Determined Cause: Software design
• Action: The firm, Carestream Health Inc., sent an "URGENT: Medical Device Recall" notice dated October 28, 2014 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to use the one-up printing option rather the multi-format printing option if a hard copy is required. Carestream has a software update that will address this issue. A Carestream service representative will contact all customers to schedule a visit to correct this software issue. If you have any questions or concerns or would like to request the installation of the previous software version that does not have this issue, 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 service support number.
• Quantity in Commerce: 59 units
• Distribution: Worldwide Distribution: US distribution to states of : NY, OH, and NC; and countries of: Argentina, Brazil, China, Chile, Colombia, France, Greece, Hong Kong, India, Japan, Korea, Mexico, Peru, Spain, Taiwan, and Thailand.
• 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 = LLZ