Toshiba American Medical Systems Inc: Medical Device Recall in 2014 - (Recall #: Z-0972-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.
Product Description:

TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.

Product Classification:

Class II

Date Initiated: December 11, 2013
Date Posted: March 12, 2014
Recall Number: Z-0972-2014
Event ID: 67227
Reason for Recall:

Toshiba America Medical Systems, Inc. initiated this recall due to the failure of the parts used in the X-ray high-voltage generator. In some cases, X-ray exposure cannot be performed.

Status: Terminated
Product Quantity: 8 units
Code Information:

SERIAL NO.: 1CB1262006, 1DB1312033, 1DC1352070, 1DB1342060, 1DB1332049, 1DC1382081, 1DB1312027, 1DB1332045, 1DC1362073, 1CB12X2018.

Distribution Pattern:

US Distribution including the states of: MD, WV, OH, CA, MN, IN, NY and WI.

Voluntary or Mandated:

Voluntary: Firm initiated