medical Class II Updated 2025-05-14

Philips Medical Systems Nederland B.V. recalls IntelliSpace Cardiovascular software versions 6.x, 7.x, and

Recalled Product

IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.


Hazard / Issue

An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model Number: 830089; Software Versions: 6x, 7.x, and 8.x; UDI-DIs: (01)00884838106970(11)211130(10)6.1.0.0 (Version 6.1.0.0), (01)00884838106970(11)220623(10)6.2.0.0 (Version 6.2.0.0), (01)00884838115378(11)221214(10)7.0.0.0 (Version 7.0.0.0), (01)00884838115378(11)230711(10)7.1.0.0 (Version 7.1.0.0), (01)00884838122000(11)240325(10)8.0.0.0 (Version 8.0.0.0).
View official government recall

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