Home / Recalls / Medical Devices
SEDECAL SA recalls MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
Recalled February 21, 2024 · FDA recall Z-1083-2024 · 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. · FDA Class II
Units
851 devices
Sold at
US Nationwide distribution. There was government distribution but no military distribution.
Description
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.
Product
MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
Manufacturer(s)
SEDECAL SA
Made in
Spain
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →