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Recall Observatory FDA recall evidence

Device product

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

Z-1897-2024

May 16, 2024

Class II

Product summary

Firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Event
Event 94647
Status
Ongoing
Classification
Class II
Quantity
1 unit (OUS)
Official record key
device-enforcement:Z-1897-2024

Official wording

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.

Code information: Product number: 722013, UDI/DI: 00884838059061; Serial Number: 232.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.