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Open, Classified

Phoenix mKDR, digital mobile diagnostic x-ray system

FDA Recall Z-1202-2023 · Posted 2023-03-02

Recalling FirmSEDECAL SA
Recall StatusOpen, Classified
Product CodeIZL
Date Initiated2023-02-06
Product Quantity53 units

Reason for Recall

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

Firm 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].

Root Cause

Device Design

Distribution Pattern

US, Argentina, Panama

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K212291PHOENIXSedecal., Sa. · 2021-09-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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