Philips Medical Systems Nederland B.V.: IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Domestic: Nationwide Distribution International: Australia, Austria, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Indonesia, Ireland, Italy, Japan, Luxembourg, Mexico, Netherlands, Norway, Poland, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom. Quantity: 996 units (267 US, 729 OUS) 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).

UPC codes

00884838106970, 00884838115378, 00884838122000

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.