Philips North America Recall 93773
Description: ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150
Philips North America Recall 93773 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1073-2024 |
| Event ID | 93773 |
| Event Description | ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150 |
| Product Type | Devices |
| Distribution | Nationwide Foreign: Australia Germany India Italy Malaysia Panama Thailand |
| Quantity | 20 units |
| Recall Reason | Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patients radiography (RAD) images when starting the next patient scan while the previous patient image export is still processing. If the issue occurs, there is a potential for incorrect patient data to be displayed in the image. Issue 2: Detector Access point: Security vulnerability specific to the Wireless Portable Detector configuration items in Philips Support Connect (PSC). Due to this vulnerability it is possible, with physical access to the system and knowledge of specific settings, to modify and export data to removable media (example: USB) |
| Device Classification | 20240221 |
| Device Code Info | UDI: N/A Serial Numbers US: 4 5 6 7 8 9 11 12 13 14 17 18 61 692222229 692222254 692222263 Serial Numbers OUS: 53 56 65 692222227 |
| Center Classification Date | 20240209 |
| Recall Initiation Date | 20231215 |
| Recalling Firm | Philips North America |
| Initial Notification | Letter |
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