Recall Z-1145-2024 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: FlexViewing PC Azurion Model Name - Model Number: Azurion 7 B12 722067; Azurion 7 B20 722068; Azurion 7 M12 722078 722223; Azurion 7 M20 722079;
| Date | Feb 16, 2024 (initiated Jan 2, 2024) |
| Status | Open, Classified |
| Reason | Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may result in delay of procedure. |
| Root cause | Process design |
| Action | On January 2, 2024, the firm notified affected consignees via URGENT Medical Device Correction letters. These letters covered issues with three components of the PCs that may not perform as intended and which may therefore lead to delay in treatment: 1) DIMMs, 2) Disk Bay, and 3) Framegrabber Card. This recall record is for the Framegrabber Card issue. Customers should circulate the notice to all users and establish an emergency protocol for if you experience the issue during a procedure. Customers were provided with monitoring activities to undertake while waiting for their system to be co |
| Quantity | 1,993 US; 2,662 ROW |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |