Philips Hemodynamic Application software pressure wave data synchronization defect

Plain-English summary

Philips Medical Systems is recalling Interventional Hemodynamic Application software (versions 1.2.0, 1.2.1, 1.2.2, 1.2.3, 1.3.0, and 1.3.1) used during invasive cardiac and vascular procedures to obtain hemodynamic data.

The software may not correctly synchronize pressure wave data when acquiring measurements from two devices at the same time. This synchronization defect could result in inaccurate hemodynamic data being reported to clinicians.

Approximately 391 units of the affected software have been distributed worldwide. Within the United States, affected installations are located in California, Indiana, and Oregon. The software was also distributed to healthcare facilities in approximately 30 additional countries.

Healthcare facilities using the affected software versions should contact Philips Medical Systems for instructions on remediation and software updates.

The recalled product

Product

Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.

Manufacturer

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Category

Medical Device — Hemodynamic Monitoring Software

Hazard

• data-synchronization-error
• measurement-error
• software-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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