Recall Z-1563-2022 ยท KPR System, X-Ray, Stationary
Philips North America Llc
DigitalDiagnost C50 1.1
| Date | Sep 1, 2022 (initiated Feb 25, 2022) |
| 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 the 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. (Added 1/3/2023), Expansion of the root cau |
| Root cause | Software Design Change |
| Action | Philips notified customers of the issue via an Electronic Product Radiation Defect notification letter dated July 12, 2022. Philips will schedule an appointment with customers to install the software update at no cost to customers. For questions contact Philips Customer Care Solutions Center 1-800-722-9377. |
| Quantity | 11 systems (updated 1/3/2023) |
| Distribution | Nationwide Distribution including Puerto Rico |
| FDA record | Open on fda.gov |