Toshiba American Medical Systems Inc Toshiba Aquilion ONE CT SystemTSX-301 A/2D Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Toshiba Aquilion ONE CT SystemTSX-301 A/2D
Brand
Toshiba American Medical Systems Inc
Lot Codes / Batch Numbers
2DA0872038, 2DA0862034, 2DA07X2008, 2DA0842023, 2DA07X2005, 2DA0882053, 2DA0882051, 2DA0862036, 2DA0882049, 2DA0882052, 2DA0842026, 2DA07Y2010, 2DA0882048, 2DA08X2061, 2DA0792004, and 2DA0792002
Products Sold
2DA0872038, 2DA0862034, 2DA07X2008, 2DA0842023, 2DA07X2005, 2DA0882053, 2DA0882051, 2DA0862036, 2DA0882049, 2DA0882052, 2DA0842026, 2DA07Y2010, 2DA0882048, 2DA08X2061, 2DA0792004, and 2DA0792002
Toshiba American Medical Systems Inc is recalling Toshiba Aquilion ONE CT SystemTSX-301 A/2D due to ECG Gated Dynamic Volume Prospective scan may stop if preset eXam Plan is confirmed and CTA On is changed to CTA OFF, due to exposure control PWB.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
ECG Gated Dynamic Volume Prospective scan may stop if preset eXam Plan is confirmed and CTA On is changed to CTA OFF, due to exposure control PWB.
Recommended Action
Per FDA guidance
Toshiba America Medical System Inc (TAMS) sent an Urgent: Medical Device Correction dated January 14, 2009 to their consignees. The letter described the issue and provided instructions to test the device to determine if it is an affected device. If the device is affected, contact the Toshiba service representative at 800 521-1968. Consignees were requested to complete and fax a response form to Toshiba.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026