Jul

2001

IncClassII Toshiba America Medical Systems

Company:Date of Enforcement Report: 7/18/01
Class: II

RECALL NUMBER, PRODUCT AND CODE<:br>
Z-0691-1 through Z-0693-1 Software used on the Computerized Tomography Fluoroscopy CT Fluroscopy option, model numbers TSXF-003A; TSXF-003B; TSXF-003C for Aquilion (Model No. TSX-101A) and Asteion (Model No. TSX-021A) Computed Tomography Scanners

REASON:
X-ray generation without operator command using unusual program sequence.

MANUFACTURER/RECALLING FIRM:
Toshiba America Medical Systems, Inc. (TAMS), Tustin, CA

RECALL BY:
Toshiba customer notification will begin 5/10/2001 which describes precautions and preventative measures.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
Nationwide.

QUANTITY:
44 units

SoftwareCPR keywords: PACS

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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IncClassII Toshiba America Medical Systems

Amy Sellers

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