Philips

飞利浦

(NYSE: PHG)

（纽约证券交易所代码：PHG）

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issued an urgent field safety notice to warn of a potential safety issue with its IntelliSpace Cardiovascular (ISCV) 7.0 system.

发布了一份紧急的现场安全通知，警告其IntelliSpace心血管（ISCV）7.0系统存在潜在的安全问题。

The letter, dated Jan. 10, 2025, was

日期为2025年1月10日的信件

published

已发布

by the German Federal Institute for Drugs and Medical Devices on Feb. 21. It outlines a potential issue with the ISCV software version 7.0.

德国联邦药品和医疗器械研究所于2月21日发布。它概述了ISCV软件版本7.0的潜在问题。

When the field “Reason for Study” in the application is populated (via HL7 or manually) into ISCV with more than 64 characters, the study data cannot be archived, exported, or copied from ISCV via DICOM or to a CD. However, the images remain available on the ISCV data base, accessible to every authorized user within the application..

当申请中的“研究原因”字段通过HL7或手动填充到ISCV中且字符数超过64个时，研究数据无法通过DICOM或导出到CD的方式从ISCV归档、导出或复制。然而，图像仍然保留在ISCV数据库中，应用程序内的每位授权用户均可访问。

As a result, users may experience an inability to archive, copy or export study data when the “Reason for Study” exceeds 64 characters. The lack of data management could result in a delay to diagnosis.

因此，当“研究原因”超过64个字符时，用户可能无法归档、复制或导出研究数据。数据管理的缺失可能会导致诊断延误。

Philips told users that they may continue to use their system in accordance with its intended use. If they fail to archive, export or copy study data due to the issue, they should update the “Reason for Study” field using less than 64 characters.

飞利浦告诉用户，他们可以继续按照预期用途使用系统。如果由于该问题未能归档、导出或复制研究数据，应使用少于64个字符更新“研究原因”字段。

The Dutch medtech giant intends to install a software solution to resolve the issue.

荷兰医疗科技巨头打算安装软件解决方案来解决这个问题。

Philips ISCV is an integrated multimodality image and information system. The company designed it to perform the necessary functions required for import, export, storage, archival, review, analysis, quantification, reporting and database management of digital medical images.

飞利浦ISCV是一个集成的多模式图像和信息系统。该公司设计它是为了执行导入、导出、存储、归档、查看、分析、量化、报告和数字医疗图像数据库管理所需的功能。

The company designed ISCV only as a supporting device during open-heart surgery and cardiac interventional procedures.

该公司设计的ISCV仅用于开胸手术和心脏介入手术过程中的辅助设备。