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U.S. Department of Health and Human Services

Class 2 Device Recall Allura Xper

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 Class 2 Device Recall Allura Xpersee related information
Date Initiated by FirmOctober 04, 2023
Date PostedSeptember 30, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0228-2024
Recall Event ID 93342
510(K)NumberK141979 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductAllura Xper IGTS Fixed Systems
Code Information Allura Xper FD10 285 Allura Xper FD10 1517 Allura Xper FD10 1634 Allura Xper FD10 177 Allura Xper FD10 764 ALLURA Xper FD10 C 249 Allura Xper FD20 2013 Allura Xper FD20 1334 Allura Xper FD20 1473 Allura Xper FD20 2110 Allura Xper FD20 2155 Allura Xper FD20 919 Allura Xper FD20 1581 Allura Xper FD20 2353 Allura Xper FD20 1811 Allura Xper FD20 2087 Allura Xper FD20 53364 Allura Xper FD20/15 172
Recalling Firm/
Manufacturer		 Philips North America
222 Jacobs St
Cambridge MA 02141-2296
For Additional Information Contact
978-482-2309
Manufacturer Reason
for Recall		Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.
FDA Determined
Cause 2		Device Design
DistributionUnited States Territories of Puerto Rico, Guam, and Virgin Islands
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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