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