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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-1202-2023
Recall Event ID 91656
510(K)Number K212291  
Product Classification System, x-ray, mobile - Product Code IZL
Product Phoenix mKDR, digital mobile diagnostic x-ray system
Code Information UDI/DI 08436046003002, Serial Numbers: PH00092, PH00093, PH00094, PH00095, PH00097, PH00098, PH00099, PH00100, PH00110, PH00111, PH00112, PH00113, PH00114, PH00115, PH00116, PH00117, PH00118, PH00135, PH00136, PH00137, PH00138, PH00139, PH00140, PH00141, PH00142, PH00143, PH00144, PH00161, PH00162, PH00163, PH00164, PH00165, PH00166, PH00167, PH00168, PH00169, PH00176, PH00177, PH00178, PH00179, PH00180, PH00181, PH00185, PH00186, PH00187, PH00188, PH00189, PH00190, PH00191, PH00192, PH00010, PH00090, PH00091
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 53 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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