Z-1202-2023Class II

Phoenix mKDR, digital mobile diagnostic x-ray system

Name: Z-1202-2023 Phoenix mKDR, digital mobile diagnostic x-ray system
Creator: Sedecal Sa
Published: 2023-02-06
License: https://open.fda.gov/license/

Sedecal S.A. / initiated 2023-02-06 / Open, Classified / root cause: design

FDA source

SEDECAL SA began a recall of Phoenix mKDR, digital mobile diagnostic x-ray system on 2023-02-06. FDA classified it as Class II and gives the reason as "Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1202-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-06
Posted: 2023-03-02
Recalling firm: Sedecal S.A.
Product: Phoenix mKDR, digital mobile diagnostic x-ray system
Product code: IZL System, X-Ray, Mobile
Reason for recall: Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
Root cause tag: design
FDA root cause: 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 [email protected].
Quantity in commerce: 53 units
Distribution: US, Argentina, Panama
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1202-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1202-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-03-02
Z-1203-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-03-02

Product code IZL

K212291Class IIPhoenixSedecal., Sa. / cleared 2021-09-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)