Recall Z-1073-2024 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Philips North America
ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150
| Date | Feb 9, 2024 (initiated Dec 15, 2023) |
| Status | Open, Classified |
| 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 |
| Root cause | Software design |
| Action | ***UPDATE*** 19 ProxiDiagnost N90 Systems (18 US & 1 OUS) added to scope as these systems were produced prior to implementation of the solution in forward production. The newly identified consignees notified on 20 Nov 2024*** Philips issued URGENT Medical Device Correction ProxiDiagnost N90 1.1 and ProxiDiagnost Upgrade on 12/15/2024. Letter states reason for recall, health risk and action to take: For Issues 1 and 2: " To avoid previous patient data from being represented as current patient data, ensure all images have been exported from the previous RAD exam before starting a new examinat |
| Quantity | 20 units: 16 units US; 4 units OUS |
| Distribution | Nationwide Foreign: Australia Germany India Italy Malaysia Panama Thailand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212837 | ProxiDiagnost N90 Philips Medical Systems Dmc GmbH, Sep 21, 2021 |