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

Recall Z-0046-2017 — Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.

U.S. FDA — Device Enforcement · United States · 2016-04-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0046-2017
Date of alert
2016-04-25
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: It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S.
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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