FDAApril 12, 2016device

Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system employs Toshibas innovative dose-reduction technologies and a fast reconstruction unit designed ...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Toshiba American Medical Systems, Inc. is recalling the TSX-035A because of a potential problem with the Aquilion Lightning CT System iStation cover falling off of the gantry.

What to do

FDA enforcement status: Terminated

Brands named

toshiba american medical systemstoshibatoshiba american

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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