FUJIFILM Healthcare Americas Corporation Recall 94090
Description: Synapse PACS - Version 7.1.000
FUJIFILM Healthcare Americas Corporation Recall 94090 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1268-2024 |
| Event ID | 94090 |
| Event Description | Synapse PACS - Version 7.1.000 |
| Product Type | Devices |
| 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. |
| Quantity | 22 units (22 OUS) |
| Recall 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. |
| Device Classification | 20240313 |
| Device Code Info | Software Version: 7.1.000; UDI: (01)854904006008(10)0701000 |
| Center Classification Date | 20240307 |
| Recall Initiation Date | 20240110 |
| Recalling Firm | FUJIFILM Healthcare Americas Corporation |
| Initial Notification | Letter |
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