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
