Recall Z-0213-2022 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Philips North America Llc
Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)
| Date | Sep 24, 2021 |
| Status | Terminated |
| Reason | When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) button at the same time, the geometry may stop reacting on movement requests (table lock-up) and X-ray imaging becomes unavailable. |
| Root cause | Software design |
| Action | On September 24, 2021, the firm sent "Urgent Medical Device Correction" recall letters to affected customers (medical facilities). Customers were informed that a software defect causes the possibility for table lock-up and unavailable X-ray imaging when the APC (accept) button and the Float Tabletop (panning) button are pressed or released at the same time. If the problem occurs, there will be a delay in procedure. ACTIONS FOR THE CUSTOMER: - Do not press or release both the APC (accept) button and the Float Tabletop (panning) button at the same time during the procedure. - If the table lo |
| Quantity | 428 (US); 581 (OUS) |
| Distribution | Domestic distribution nationwide. International distribution worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181830 | Azurion R2.0 Philips Medical Systems Nederland B.V., Aug 2, 2018 |