—#199808

Product

Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 722221; (2) Azurion 3M15: 722064, 722222; (3) Azurion SM12: 722227; (4) Azurion SM20: 722228; (5) Azurion 7B12/12: 722067, 722225; (6) Azurion 7820/15: 722068, 722226; (7) Azurion 7M12: 722078, 722223; (8) Azurion 7M20 : 722079, 722224

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K181830
Affected lot / code info: UDI-DI: System product name Model number UDI (1)Azurion 3M12: 722063 (01)00884838085275(21) 722221 (01)00884838099203(21); (2) Azurion 3M15: 722064 (01)00884838085282(21) 722222 (01)00884838099210(21); (3) Azurion SM12: 722227 (01)00884838099227(21); (4) Azurion SM20: 722228 (01)00884838099234(21); (5) Azurion 7B12/12: 722067 (01)00884838085350(21) 722225 (01)00884838099265(21); (6) Azurion 7820/15: 722068 (01)00884838085367(21) 722226 (01)00884838099272(21); (7) Azurion 7M12: 722078 (01)00884838085251(21) 722223 (01)00884838099241(21); (8) Azurion 7M20: 722079 (01)00884838085268(21) 722224 (01)00884838099258(21), Software: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6

Why it was recalled

Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Philips issued Urgent Medical Device Letter to US consignees via e-mail on March 21, 2023 and certified email on March 29, 2023. Letters outside of the U.S.A. will be distributed through the local Philips Organizations. Letter states reason for recall, health risk and action to take: Keep this Medical Device Correction with the documentation of the system until Philips corrects your system. Circulate this notice to all users of the system so that they are aware of the issue. Return the attached reply form to Philips to confirm that the users of the system have reviewed and understood this Medical Device Correction. US: Please return this signed form via email to: IGT_Recalls@philips.com or alternatively via regular mail to Philips at 222 Jacobs Street, Cambridge, MA 02141 for the attention of Mr. Roland Telson / 3rd Floor Philips is working on a software release that will correct this issue (reference FCO72200528). In the interim, until this software is available and installed in your affected system(s), Philips will be removing the Log Trace Files from the affected systems to free up disk capacity (reference FCO72200529). Philips will be prioritizing these activities based on the time the affected software release has been installed in the Philips Azurion system. You will be contacted by your local Philips representative to schedule these activities. If you need any further information or support concerning this issue, contact your local Philips representative.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Foreign: Algeria Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Cambodia Chile China Colombia Costa Rica C¿te D'Ivoire Croatia Cyprus Czech Republic Denmark Dominican Rep Ecuador Egypt Estonia Finland France French Polynesia Germany Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy Japan Jordan Kazakhstan Kenya Korea, Republic of Kosovo Kuwait Latvia Lebanon Lithuania Macao Macedonia Malaysia Mexico Morocco Myanmar Nepal Netherlands New Zealand Nicaragua Nigeria Norway Oman Pakistan Palestine Palestine, State of Panama Peru Philippines Poland Portugal Puerto Rico Qatar Romania Russian Federation Saudi Arabia Senegal Serbia Singapore Slovakia Slovenia South Africa South Korea Spain Sri Lanka Sweden Switzerland Taiwan Thailand Tunisia Turkey Turkmenistan Ukraine United Kingdom Utd.Arab.Emir. Uzbekistan Vietnam Yemen

Timeline

Recall initiated: 2023-03-21
Posted by FDA: 2024-09-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #199808. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.