Recall Z-1268-2024 ยท LLZ System, Image Processing, Radiological
FUJIFILM Healthcare Americas Corporation
Synapse PACS - Version 7.1.000
| Date | Mar 7, 2024 (initiated Jan 10, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | 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 essent |
| Quantity | 22 units (22 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190232 | Synapse PACS Fujifilm Corporation, Mar 26, 2019 |