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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Recall 94647

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

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Recall 94647 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1897-2024
Event ID94647
Event DescriptionPhilips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1.100.
Product TypeDevices
DistributionDomestic: OK International: India, Spain, U.A.E.
Quantity1 unit (OUS)
Recall ReasonWhen 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.
Device Classification20240605
Device Code InfoProduct number: 722013, UDI/DI: 00884838059061; Serial Number: 232.
Center Classification Date20240524
Recall Initiation Date20240516
Recalling FirmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Initial Notification Letter
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