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

Recall Z-1068-2013 — Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.

U.S. FDA — Device Enforcement · United States · 2012-11-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1068-2013
Date of alert
2012-11-14
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: Due to a problem with the control software of the x-ray high-voltage generator, if scanning is performed with a tube current less than 30mA, the control software may detect an error and perform error processing even though the x-ray output is normal.
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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