Mar

2014

ElektaTSX-301C Aquilion One Cl II

Company:Elekta, Inc.
Date of Enforcement Report:3/12/2014
Class lI:

PRODUCT

TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.
Recall Number Z-0972-2014

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.

RECALLING FIRM/MANUFACTURER
Elekta Inc., Atlanta GA. on 11/25/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
8 units

DISTRIBUTION
Nationwide

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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ElektaTSX-301C Aquilion One Cl II

Amy Sellers

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