Philips Medical Systems Nederland B.V. recalled its IntelliSpace Cardiovascular Software 8.0.0.4 on August 8, 2025. The recall affects four units distributed nationwide, particularly in Georgia, North Carolina, and Texas. The software displays outdated information, posing a significant risk to patient safety.
Software issue that results in the display of outdated information.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips Medical Systems Nederland B.V. or your healthcare provider for instructions. Notification method: Letter
The recall involves IntelliSpace Cardiovascular Software version 8.0.0.4. A total of four units were distributed across the United States, specifically in Georgia, North Carolina, and Texas.
The software issue results in the display of outdated medical information. This could lead to incorrect diagnoses or treatment decisions by healthcare providers.
No specific incidents have been reported. However, the potential for serious harm due to outdated information constitutes a high hazard level.
Stop using the software immediately. Follow the recall instructions from Philips Medical Systems or your healthcare provider for further guidance.
For more information, contact Philips Medical Systems Nederland B.V. or visit https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2543-2025.
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