SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain Phoenix mKDR, digital mobile diagnostic x-ray system Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Phoenix mKDR, digital mobile diagnostic x-ray system
Brand
SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain
Lot Codes / Batch Numbers
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
Products Sold
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
SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain is recalling Phoenix mKDR, digital mobile diagnostic x-ray system due to Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026