Class 2 Device Recall DigitalDiagnost C50

• Date Initiated by Firm: February 25, 2022
• Date Posted: September 01, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1563-2022
• Recall Event ID: 90728
• 510(K)Number: K163410 K201725
• Product Classification: System, x-ray, stationary - Product Code KPR
• Product: DigitalDiagnost C50 1.1
• Code Information: Model Number 712204 Serial Number 210182 210187 220002 210049 210051 210097 210052 210053 210055 220020
• Recalling Firm/ Manufacturer: Philips North America Llc; 222 Jacobs St; Cambridge MA 02141-2289
• For Additional Information Contact: Dusty Leppert, CHP ; 978-228-0190
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 in Commerce: 11 systems (updated 1/3/2023)
• Distribution: Nationwide Distribution including Puerto Rico
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KPR and Original Applicant = Philips Healthcare (Suzhou) Co., Lit.; 510(K)s with Product Code = KPR and Original Applicant = PHILIPS HEALTHCARE (SUZHOU) CO., LTD.