FDAFDA · Food and drugs·Recall number Z-0972-2014
TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.
Published March 12, 2014 · Recall initiated: December 11, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Toshiba American Medical Systems Inc
- Distributor
- US Distribution including the states of: MD, WV, OH, CA, MN, IN, NY and WI.
- Lot
- SERIAL NO.: 1CB1262006, 1DB1312033, 1DC1352070, 1DB1342060, 1DB1332049, 1DC1382081, 1DB1312027, 1DB1332045, 1DC1362073, 1CB12X2018.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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