—#206021

Product

Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722227 (2) 722228

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K200917
Affected lot / code info: OUS (1) Model: 722227 SN: UDI: 75 (01)00884838099227(21)75 122 (01)00884838099227(21)122 131 (01)00884838099227(21)131 132 (01)00884838099227(21)132 165 (01)00884838099227(21)165 116 (01)00884838099227(21)116 136 (01)00884838099227(21)136.' (2) Model: 722228 Serial Number UDI 168 (01)00884838099234(21)168 197 (01)00884838099234(21)197 154 (01)00884838099234(21)154 193 (01)00884838099234(21)193 165 (01)00884838099234(21)165 163 (01)00884838099234(21)163 139 (01)00884838099234(21)139 202 (01)00884838099234(21)202 141 (01)00884838099234(21)141 200 (01)00884838099234(21)200 174 (01)00884838099234(21)174 178 (01)00884838099234(21)178 147 (01)00884838099234(21)147 208 (01)00884838099234(21)208 171 (01)00884838099234(21)171 167 (01)00884838099234(21)167 194 (01)00884838099234(21)194 176 (01)00884838099234(21)176 228 (01)00884838086777(10)2.0.0.10015 161 (01)00884838099234(21)161

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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).

Recalling firm

Firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2024-02-06
Posted by FDA: 2024-02-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.