Class 2 Device Recall Konica Minolta

• Date Initiated by Firm: February 06, 2023
• Date Posted: March 02, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1203-2023
• Recall Event ID: 91656
• 510(K)Number: K221803
• Product Classification: System, x-ray, mobile - Product Code IZL
• Product: Phoenix mKDR Xpress, digital mobile diagnostic x-ray system
• Code Information: UDI/DI 08436046003163, Serial Numbers: PH00202, PH00203, PH00204, PH00205, PH00206, PH00207, PH00208
• Recalling Firm/ Manufacturer: SEDECAL SA; PELAYA, 9 POL.; POL. IND. RIO DE JANEIRO; Algete Spain
• For Additional Information Contact: Maria Luisa Gomez de Ag¿ero Gomez; 8473946960
• Manufacturer Reason for Recall: Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
• FDA Determined Cause: Device Design
• Action: Sedecal issued an URGENT MEDICAL DEVICE RECALL notice to its US distributor on 02/06/2023 by email. The notice explained the issue and requested that distributor to warn its customers about the risk of potential erratic movement and provided a list of precautions until the software is installed. Questions may be directed to calidad-clientes@sedecal.com.
• Quantity in Commerce: 7 units
• Distribution: US, Argentina, Panama
• 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 = IZL