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Recall Observatory FDA recall evidence

Device product

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

Z-0972-2014

December 11, 2013

Class II

Product summary

Firm
Toshiba American Medical Systems Inc
Event
Event 67227
Status
Terminated
Classification
Class II
Quantity
8 units
Official record key
device-enforcement:Z-0972-2014

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.