Company: Toshiba America Medical Systems, Inc.
Date of Enforcement Report: 7/18/01
Class: II

RECALL NUMBER, PRODUCT AND CODE:
Z-0690-1, Impax Technology Inc. DDS Intended use is as Diagnostic Image Display Software Model/catalog number: DS3000, CS5000, XA3000

REASON:
Wrong image presents to radiologist upon database query.

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

RECALL BY:
TAMS reports that one unit located in PA is being returned and is not in service. TAMS has requested the software update in CDROM form and will update the second unit located at UCLA @ Oliveview.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
CA and PA

QUANTITY:
2 units

SoftwareCPR Keywords: PACS