Recall Z-1203-2023— SEDECAL SA
Class II · Ongoing
Class II FDA medical device recall by SEDECAL SA, initiated 2023-02-06. It names one FDA 510(k) clearance: K221803. Product: Phoenix mKDR Xpress, digital mobile diagnostic x-ray system. Reason: Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems..
- Recalling firm
- SEDECAL SA
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-02-06
- Firm location
- Algete, N/A, Spain
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Phoenix mKDR Xpress, digital mobile diagnostic x-ray system
Reason for recall
Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
Data sourced from openFDA. This site is unofficial and independent of the FDA.