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U.S. Department of Health and Human Services

Class 2 Device Recall Azurion R2.1

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  Class 2 Device Recall Azurion R2.1 see related information
Date Initiated by Firm February 06, 2024
Date Posted February 22, 2024
Recall Status1 Open3, Classified
Recall Number Z-1176-2024
Recall Event ID 93966
510(K)Number K200917  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures
Models:
(1) 722221
(2) 722222
(3) 722280
Code Information OUS: (1) Model: 722221 SN: 66 (01)00884838099203(21)66; SN: 91 (01)00884838099203(21)91; SN: 104 (01)00884838099258(21)104, (2) Model: 722222 SN: UDI: 165 (01)00884838099210(21)165 183 (01)00884838099210(21)183 189 (01)00884838099210(21)189 182 (01)00884838099210(21)182 185 (01)00884838099210(21)185 159 (01)00884838099210(21)159 184 (01)00884838099210(21)184 190 (01)00884838099210(21)190 174 (01)00884838099210(21)174 177 (01)00884838099210(21)177 (3)Model: 722280 20 (01)00884838103276(21)20
Recalling Firm/
Manufacturer		 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Veenpluis 4-6
Best Netherlands
Manufacturer Reason
for Recall		 Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.
FDA Determined
Cause 2		 Under Investigation by firm
Action Philips notified U.S customers by Urgent Medical Device Correction letter on 06-Feb-2024 via certified mailing via United States Postal Service. " Letters outside of the U.S.A. will be distributed through the Philips Markets Organizations. Letter states reason for recall, health risk, and action to take: Circulate this Letter to all clinical staff and any service personnel that may service the system so that they are aware of the issue. " Keep this Urgent Medical Device Correction Letter with the documentation of the system until Philips implements the correction in your system. " If the Certeray generator fails, please stop using the system and contact the Customer Care Solutions Center. " Place a copy of this Letter in a visible place in the Control and Technical rooms (e.g., posted on the door). " Please complete and return the attached response form (on page 3) to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction and understanding of the issue and required actions to be taken. 5. Actions planned by Philips IGTS to correct the problem As a remedy, Philips will replace the Power Inverter in the Azurion generator cabinet in all affected Azurion systems through the implementation of Field Change Order (FCO72200544). If you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).
Quantity in Commerce 14 units
Distribution Worldwide distribution - US Nationwide distribution in the states of NY, PA, PR, TN, TX, VA, WA and the countries of Algeria, Armenia, Austria, Brazil, China, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Kazakhstan, Korea, Republic of Kuwait, Lithuania, Macao, Macedonia, Malaysia, Morocco, Netherlands, Norway, Oman, Palestine, State of Panama, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, United Kingdom.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = OWB and Original Applicant = Philips Medical Systems Nederland BV
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