Synapse PACS - Version 7.1.000US
FDA device recall Z-1269-2024 · posted 2024-03-07 · Open, Classified
Recall details
- Recalling firm
- FUJIFILM Healthcare Americas Corporation
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- LLZ
- Quantity affected
- 3 Units (3 US)
- 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, P
- Date initiated
- 2024-01-10
- Date posted
- 2024-03-07
- Location
- Lexington, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Synapse PACS (K190232) | Fujifilm Corporation | 2019-03-26 |