Philips Healthcare Recall 89020
Description: Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
Philips Healthcare Recall 89020 Information
| Status | Ongoing |
| Mandated? | FDA Mandated |
| Recall Number | Z-0238-2022 |
| Event ID | 89020 |
| Event Description | Philips Azurion systems with software releases 2.1(L1) and 2.1(L2) |
| Product Type | Devices |
| Distribution | US Nationwide distribution |
| Quantity | 226 units |
| Recall Reason | 3D-RA is a reconstruction software product that can be used with the Philips Azurin system. This product extends the functionality of compatible X-ray equipment with the capability of 3D X-ray imaging. Before starting a 3D-RA scan, the detector of the Philips Azurion system must be positioned in portrait or landscape orientation with an angle of 0 or +/-90 degrees relative to the 3D scan direction. Philips has discovered that Azurion releases 2.1(L1) and 2.1(L2) allow creation of a 3D-RA scan with a deviating detector orientation of up to 3 degrees from the exact portrait or landscape orientation (i.e., at 0 or +/-90 degrees), relative to the 3D scan direction. 3D-RA scans with a deviating detector orientation of ore than 1.0 degree from the exact portrait or landscape orientation (i.e., at 0 or +/-90 degrees) cannot be reconstructed with the 3D-RA reconstruction software. |
| Device Classification | 20211201 |
| Device Code Info | Azurion 2.1(L1) and 2.1(L2) |
| Center Classification Date | 20211124 |
| Recall Initiation Date | 20210924 |
| Recalling Firm | Philips Healthcare |
| Initial Notification | Letter |
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