FDA recall Z-1083-2024

SEDECAL SA · Class II · device

Product

MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007

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.

Key facts

Status
Ongoing
Initiation date
2021-10-14
Report date
2024-02-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Algete, N/A, Spain

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1083-2024