Software issue may impact study data management
Philips has issued an urgent field safety notice for its IntelliSpace Cardiovascular (ISCV) 7.0 system in Europe due to a potential software issue.
Key Issue
- If the “Reason for Study” field exceeds 64 characters, study data cannot be archived, exported, or copied via DICOM or CD.
- Images remain available within ISCV for authorized users.
- The issue may delay diagnosis if data management is affected.
Philips’ Response
- Users may continue using the system but should limit text entry in the affected field.
- A software update is planned to resolve the issue.
ISCV is an integrated multimodality image and information system designed to support cardiac procedures and open-heart surgeries.
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