Philips Allura Xper FD10 System (PHILIPS) – Brake Engagement Issue (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.
Brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands
Lot Codes / Batch Numbers
Product number: 722010, UDI/DI: 00884838059030, Serial Numbers: 774, 909, 526.
Products Sold
Product number: 722010, UDI/DI: 00884838059030; Serial Numbers: 774, 909, 526.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands is recalling Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Versio due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On May 14, 2024 URGENT Medical Device Correction letters were sent to consignees. Actions that should be taken by the customer / user to lower risks for patients: " Circulate this Urgent Medical Device Correction letter to all users so that they are aware of the issue. " Philips recommends discontinuing use of the system for procedures that can be safely postponed to another time, or for procedures that can be performed with another system. " Keep this Urgent Medical Device Correction letter with the documentation of the system until Philips corrects your system. Ensure the letter is in a place likely to be seen/viewed. " Please complete and return the attached response form (on page 3) to Philips promptly and no later than 15 days from receipt. Completing this form confirms receipt of the Medical Device Correction letter and understanding of the issue and required actions to be taken. 5. Actions planned by Philips IGT-S to correct the issue: Philips will be re-installing the previous software release in all affected systems. Philips will contact affected customers immediately to schedule a visit to perform this software change (reference FCO72200588). If you need additional information or support concerning this issue, please contact your local Philips representative at 1-800-722-9377 (Philips Customer Care Solutions Center).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
OK
Page updated: Jan 10, 2026