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

Recall Z-1104-2013 — Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.

U.S. FDA — Device Enforcement · United States · 2012-12-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1104-2013
Date of alert
2012-12-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Toshiba American Medical Systems Inc
Product category
device
Product type
Devices
Reported risk: Toshiba Medical Systems has received reports of startup issues with the Toshiba TUS-500 and TUS-300 ultrasound systems. The startup issue is predominant when attempting to bring the system up from standby mode when the system is used remotely. It has been determined that this may potentially cause damage to the system.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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