Z-0878-2021 Class II Ongoing
FDA device recall Z-0878-2021 was initiated by Fujifilm Medical Systems U.S.A., Inc. on September 11, 2020 and is designated Class II. Reason for recall: There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned… The recall status is ongoing. Affected quantity: 235.
Recall Details
- Product Type
- Devices
- Report Date
- January 27, 2021
- Initiation Date
- September 11, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 235
Product Description
Synapse PACS Software Versions 5.1 and higher
Reason for Recall
There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modality.
Distribution Pattern
Software was distributed to medical facilities nationwide throughout the U.S.
Code Information
Software Versions 5.1, 5.2, 5.3, 5.4, 5.5, and 5.7.