The Recall Desk
HighFDA (Devices)·Z-1897-2024·Announced 2024-06-05

Philips Allura Xper FD20 Software Update Disables Pivot Brake on Patient Table

A software upgrade to Philips Allura Xper FD20 Biplane systems causes the patient table pivot brake to fail to engage, potentially causing unexpected table movements during procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving failure of a safety mechanism (pivot brake disengagement) that could cause unexpected patient table movement during procedures. No injuries, deaths, or illnesses have been reported in the source material. This qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling the Allura Xper FD20 Biplane system with an ADN7NT patient table (Model 722013, Software Version 8.1.100). When Software upgrade 8.1.100 is installed on this system, the pivot brake does not engage.

The failure of the pivot brake to engage may cause unexpected movements of the patient table. This poses a potential risk of injury during medical procedures.

This recall affects one unit that has been distributed to locations including Oklahoma (domestic distribution) and India, Spain, and the United Arab Emirates (international distribution).

Healthcare facilities with this equipment should contact Philips Medical Systems for guidance on remediation or system updates.

The recalled product

Product
Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1.100.
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Hazard
  • brake-failure
  • unexpected-movement
  • injury-risk

Is your product affected?

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

Lot numbers (3)

  • Product number: 722013
  • UDI/DI: 00884838059061
  • Serial Number: 232.

Distribution

Distributed in 1 state:

  • OK