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U.S. Department of Health and Human Services

Class 2 Device Recall Azurion FlexArm

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 Class 2 Device Recall Azurion FlexArmsee related information
Date Initiated by FirmMarch 12, 2019
Create DateApril 11, 2019
Recall Status1 Terminated 3 on October 07, 2020
Recall NumberZ-1130-2019
Recall Event ID 82469
510(K)NumberK181830 
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
ProductAzurion FlexArm, 722079
Code Information Serial numbers 637, 638
Recalling Firm/
Manufacturer		 Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information ContactTechnical Support Line
800-722-9377
Manufacturer Reason
for Recall		During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not according to specification. This resulted in damage of the 24V power cable of the detector.
FDA Determined
Cause 2		Component design/selection
ActionOn March 12, 2019, the firm distributed Urgent Medical Device Correction letters to affected consignees, alerting customers that the cable set in the C-arc of the Azurion R2.0 was not according to specifications, which resulted in damage of the 24V power cable of the detector. Customers were asked to place a copy of the field safety notice together with the documentation of the system until the system is inspected and corrected (if applicable) by Philips. The firm will inspect the affected systems free of charge and correct as necessary. If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377.
Quantity in Commerce2
DistributionDistributed to one account in Florida, and one international account in Germany.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JAA
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