SEDECAL SA: Medical Device Recall in 2023 - (Recall #: Z-1202-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Phoenix mKDR, digital mobile diagnostic x-ray system

Product Classification:

Class II

Date Initiated: February 6, 2023

Date Posted: March 8, 2023

Recall Number: Z-1202-2023

Event ID: 91656

Reason for Recall:

Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.

Status: Ongoing

Product Quantity: 53 units

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

Distribution Pattern:

US, Argentina, Panama

Voluntary or Mandated:

Voluntary: Firm initiated