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U.S. Department of Health and Human Services

Class 2 Device Recall Veradius Unity

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 Class 2 Device Recall Veradius Unitysee related information
Date Initiated by FirmOctober 04, 2023
Date PostedSeptember 30, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0230-2024
Recall Event ID 93342
510(K)NumberK142708 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductVeradius Unity Mobile Surgery C-arm
Code Information Veradius Neo 497 Veradius Neo 607 Veradius Neo 619
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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