Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1
Summary
The FDA issued a Class II for Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Num by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. 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 une.
Details
Source
Device Recall
External ID
Z-1897-2024
Action Date
2024-06-05
Status
Ongoing
Category
device
Product Description
Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1.100.
Lot/Code Info: Product number: 722013, UDI/DI: 00884838059061; Serial Number: 232.
Quantity Affected: 1 unit (OUS)
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-16
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 258 device recalls issued in the same week, part of 413 device-related FDA actions this month.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 236 FDA actions in our database, including 203 recalls and 33 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. have FDA actions?
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 236 FDA actions in our database, including 203 recalls and 33 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1897-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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