FDA-Device2024-02-21Class II
MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
SEDECAL SA
Hazard
While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button. This would result in the system moving on its own in a very slow speed forward circular motion.
Sold states
US Nationwide distribution. There was government distribution but no military distribution.
Affected count
851 devices
Manufactured in
PELAYA, 9 POL., POL. IND. RIO DE JANEIRO, Algete, N/A, Spain
Products
MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1083-2024Don't want to check this manually?
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