FDA Recall: Software Upgrade Issue Leading to Table Pivot Brake Not Engaging

Company: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Date of Enforcement Report: 5/24/2024
Class II

PRODUCT

Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100.

Recall Number:

Z-1895-2024

REASON:

When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.

RECALLING FIRM/MANUFACTURER:

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

VOLUME OF PRODUCT IN COMMERCE:

1 unit (US)

DISTRIBUTION:

Domestic: OK International: India, Spain, U.A.E.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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