—#195576

Product

DigitalDiagnost C50 1.1

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K163410, K201725
Affected lot / code info: Model Number 712204 Serial Number 210182 210187 220002 210049 210051 210097 210052 210053 210055 220020

Why it was recalled

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 cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting.

Root cause (FDA determination)

Software Design Change

Action the firm took

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.

Recalling firm

Firm: Philips North America Llc
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

Distribution pattern: Nationwide Distribution including Puerto Rico

Timeline

Recall initiated: 2022-02-25
Posted by FDA: 2022-09-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #195576. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.