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U.S. Department of Health and Human Services

Class 2 Device Recall ASPIRE Cristalle

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  Class 2 Device Recall ASPIRE Cristalle see related information
Date Initiated by Firm July 14, 2017
Date Posted January 17, 2018
Recall Status1 Terminated 3 on July 20, 2018
Recall Number Z-0386-2018
Recall Event ID 78891
510(K)Number K133972  
Product Classification Full field digital,system,x-ray,mammographic - Product Code MUE
Product ASPIRE Cristalle (FDR MS-3500) Mammography machine

The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.
Code Information FDR MS-3500 : S/N- 76221095 or earlier
Recalling Firm/
Manufacturer		 Fujifilm Medical Systems U.S.A., Inc.
419 West Ave
Stamford CT 06902-6343
For Additional Information Contact Randy Vader
360-356-6821
Manufacturer Reason
for Recall		 There was a case that the swivel arm went down unintentionally when it was moved up/down.
FDA Determined
Cause 2		 Employee error
Action FUJIFILM sent an Urgent: Medical Device Correction Letter dated July 14, 2017, accompanied by a Customer Feedback form to customers. PLEASE READ AND FOLLOW THE INSTRUCTIONS Please refer to the following page which provides the details of the problem and instructions for actions to be taken. Please follow the instructions in the ACTIONS TO BE TAKEN BY CUSTOMER/USER section. We sincerely regret the inconvenience that this may cause you. FUJIFILM is committed to providing products and services of the highest quality. Your satisfaction with FUJIFILM products and with our response to this issue is very important to us. If you have any questions about this matter, please contact your local FUJIFILM office. For further questions, please call (360) 356-6821.
Quantity in Commerce 15 US 1 OUS
Distribution US Distribution and Internationally to Mexico.
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 = MUE and Original Applicant = FUJIFILM MEDICAL SYSTEMS, USA INC.
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