Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1083-2024 — MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007

U.S. FDA — Device Enforcement · Spain · 2021-10-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1083-2024
Date of alert
2021-10-14
Country / jurisdiction
Spain
Risk level
Class II
Risk type
recall
Brand
SEDECAL SA
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00884838028586
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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