PlainRecalls
FDA Devices Moderate Class II Ongoing

Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1.100.

Reported: June 5, 2024 Initiated: May 16, 2024 #Z-1897-2024

Product Description

Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1.100.

Reason for Recall

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.

Details

Units Affected
1 unit (OUS)
Distribution
Domestic: OK International: India, Spain, U.A.E.
Location
Best

Frequently Asked Questions

What product was recalled?
Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1.100.. Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Units affected: 1 unit (OUS).
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 5, 2024. Severity: Moderate. Recall number: Z-1897-2024.