FDA-Device2023-03-08Class II
Phoenix mKDR, digital mobile diagnostic x-ray system
SEDECAL SA
Hazard
Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
Sold states
US, Argentina, Panama
Affected count
53 units
Manufactured in
PELAYA, 9 POL., POL. IND. RIO DE JANEIRO, Algete, N/A, Spain
Products
Phoenix mKDR, digital mobile diagnostic x-ray system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1202-2023Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief