Class II

Medical Device Recall: MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007

SEDECAL SA · October 14, 2021

Reason for Recall

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.

Distribution

US Nationwide distribution. There was government distribution but no military distribution.

States Affected

NATIONWIDE

Quantity Affected

851 devices

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1083-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.