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U.S. Department of Health and Human Services

Class 2 Device Recall Synapse PACS

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  Class 2 Device Recall Synapse PACS see related information
Date Initiated by Firm January 10, 2024
Date Posted March 07, 2024
Recall Status1 Open3, Classified
Recall Number Z-1271-2024
Recall Event ID 94090
510(K)Number K190232  
Product Classification System, image processing, radiological - Product Code LLZ
Product Synapse PACS - Version 7.2.100
Code Information Software Version: 7.2.100, UDI: (01)854904006008(10)0702100
Recalling Firm/
Manufacturer		 FUJIFILM Healthcare Americas Corporation
81 Hartwell Ave Ste 300
Lexington MA 02421-3160
For Additional Information Contact Kotei Aoki
617-861-5300
Manufacturer Reason
for Recall		 Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
FDA Determined
Cause 2		 Software design
Action URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers January 26, 2024. In an abundance of caution, FUJIFILM is recommending that customer/end users take one of the following actions until the correction is applied: 1. To not perform measurements on Secondary Capture Images that are displayed together with Breast Tomo Images. 2. Ensure Secondary Capture Image has valid pixel spacing values using the DICOM Header Tool. Please complete and return the Field Action Verification Form attached on page 3 of this communication. Providing the response with the information requested is essential for ensuring appropriate action is taken. Please contact our field action coordinator, Kotei Aoki, via phone at 765-246-2931 or email at kotei.aoki@fujifilm.com, if you have any further questions regarding this field action. Please keep a copy of this letter with your instructions for use.
Quantity in Commerce 35 Units (28 US, 7 OUS)
Distribution Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Australia, Belgium, Brazil, Canada, Colombia, Ecuador, France, Germany, India, Italy, Mexico, Namibia, Netherlands, Portugal, Qatar, Spain, Thailand, Turkey, UAE, United Kingdom.
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 = LLZ and Original Applicant = FUJIFILM Corporation
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