Phoenix mKDR, digital mobile diagnostic x-ray system recallZ-1202-2023 · Sedecal SA · initiated Feb 6, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Sedecal SA or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
FDA root cause category: Device Design
What the company is doing
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].
Recall details
- Recall number
- Z-1202-2023
- Status
- Open, Classified
- Initiated by the company
- Feb 6, 2023
- Posted by the FDA
- Mar 2, 2023
- Recalling firm
- Sedecal SA
- Quantity
- 53 units
- Product code
- IZL
- FDA submissions
- K212291
- Distribution
- US, Argentina, Panama
Product description
Phoenix mKDR, digital mobile diagnostic x-ray system
Code information (models, lots, serial 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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SEDECAL PhoeniXSedecal · Solid State X-Ray Imager (Flat Panel/Digital Imager)1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 91656).
- Z-1203-2023 · Open, ClassifiedPhoenix mKDR Xpress, digital mobile diagnostic x-ray system
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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