Recall Z-0835-2024 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -722063, 722221; Azurion 3M15 - 722064, 722222; Azurion 5M12 - 722227; Azurion 5M20 - 722228; Azurion 7B12/12 - 722067, 722225; Azurion 7B20/15 - 722068, 722226; Azurion 7M12 - 722078, 722223; Azurion 7M20 - 722079, 722224; Azurion 3 M15 (China) - 722280;
| Date | Jan 26, 2024 (initiated Dec 12, 2023) |
| Status | Open, Classified |
| Reason | System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a procedure, there may be a delay and/or abortion of the procedure. |
| Root cause | Under Investigation by firm |
| Action | On December 12, 2023, the firm notified customers via certified mailing of URGENT Medical Device Correction letters. Customers may identify affected products by the system product name and model number, which can be found on the System Identification Label located on the system stand. The software version of the Philips Azurion system can be identified during start-up. Customers were advised to keep the number of studies in the patient database as low as possible, but at least below 500. Customers should keep the Urgent Medical Device Correction letter with the documentation of the system un |
| Quantity | 1,799 US; 5,747 OUS |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200917 | Azurion R2.1 Philips Medical Systems Nederland B.V., May 1, 2020 |