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U.S. Department of Health and Human Services

Class 2 Device Recall Konica Minolta

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  Class 2 Device Recall Konica Minolta see related information
Date Initiated by Firm February 06, 2023
Date Posted March 02, 2023
Recall Status1 Open3, 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 2
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 and Original Applicant = SEDECAL SA
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