FDA recall Z-1897-2024

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II · device

Product

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.

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2024-05-16
Report date: 2024-06-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Best, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1897-2024