FDA Medical Device Recalls (openFDA)
SEDECAL SA: Phoenix mKDR, digital mobile diagnostic x-ray system
- Recall number
- Z-1202-2023
- Recalling firm
- SEDECAL SA
- Product
- Phoenix mKDR, digital mobile diagnostic x-ray system
- Status
- Open, Classified
- Initiated
- 2023-02-06
- Posted
- 2023-03-02
- Terminated
- not on file
- Reason
- Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
- 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 calidad-clientes@sedecal.com.
- Quantity
- 53 units
- Distribution
- US, Argentina, Panama
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K212291"]
- PMA numbers
- not on file
- Product code
- IZL
- Firm FEI
- 3002495042
- Firm city
- Algete
- Firm state
- not on file
- Firm country
- Spain
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28