Recall Z-1325-2022 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Philips Medical Systems DMC GmbH
ProxiDiagnost N90. radiography and fluoroscopy system
| Date | Jul 12, 2022 (initiated May 19, 2021) |
| Status | Open, Classified |
| Reason | Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Updated 1/30/23) Expansion of the root cause t |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Philips sent an Electronic Product Radiation Defect notification letter dated May 25, 2022 to affected customers. Philips will schedule an appointment with customers to install the software update. Philips will, without charge bring the product into compliance. Customers were instructed to complete and return the attached response form to Philips. For further information or support concerning this issue, please contact Philips Customer Care Solutions Center: 1-800-722-9377 and reference FCO71200223 for impacted DigitalDiagnost systems or FCO70600109 for impacted ProxiDiagnost systems. |
| Quantity | 140 systems in total, (Updated 1/30/2023). |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212837 | ProxiDiagnost N90 Philips Medical Systems Dmc GmbH, Sep 21, 2021 |