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)
Recall
- Recall Number
- Z-0213-2022
- Event Number
- 88854
- Firm
- Philips North America Llc
- FEI Number
- 3016618143
- Product Code
- JAA
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- September 24, 2021
- Terminated
- September 26, 2024
- Address
- 222 Jacobs St, Cambridge, MA, 02141-2289
Description
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)
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.
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 locks up, do not perform a cold restart. It will take 6 minutes until the system is fully available again. - If the table locks up, perform a warm restart. With a warm restart the system will be fully functional after 90 seconds. Fluoroscopy will be available after 60 seconds. - Place the recall letter with the documentation of the system until Philips has installed the software update in your system. - Return the reply form attached to the recall letter. System restart options are described in section 4.2 of the Instructions for Use. The problem will be resolved by a software update. Customers will be contacted by their local Philips representative to schedule the software update for your system. If you need further information, please contact your local Philips representative: 1-800-722-9377 (reference FCO72200494)
Domestic distribution nationwide. International distribution worldwide.
428 (US); 581 (OUS)