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U.S. Department of Health and Human Services

Class 2 Device Recall Allura Xper series

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 Class 2 Device Recall Allura Xper seriessee related information
Date Initiated by FirmMay 16, 2024
Date PostedMay 24, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1897-2024
Recall Event ID 94647
510(K)NumberK162859 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductPhilips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1.100.
Code Information Product number: 722013, UDI/DI: 00884838059061; Serial Number: 232.
FEI Number 3002807880
Recalling Firm/
Manufacturer		 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Veenpluis 4-6
Best Netherlands
For Additional Information ContactVirginia Huete
31-615-679227
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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).
Quantity in Commerce1 unit (OUS)
DistributionDomestic: OK International: India, Spain, U.A.E.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OWB
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