SEDECAL SA: Medical Device Recall in 2023 - (Recall #: Z-1203-2023)

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 Xpress, digital mobile diagnostic x-ray system

Product Classification:

Class II

Date Initiated: February 6, 2023

Date Posted: March 8, 2023

Recall Number: Z-1203-2023

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: 7 units

Code Information:

UDI/DI 08436046003163, Serial Numbers: PH00202, PH00203, PH00204, PH00205, PH00206, PH00207, PH00208

Distribution Pattern:

US, Argentina, Panama

Voluntary or Mandated:

Voluntary: Firm initiated