Company: Toshiba American Med Systems, Inc
Date of Enforcement Report: 7/20/05
Class: II
PRODUCT
Magnetic Resonance Imaging Systems; Visart, Excelart / Excelart P2 / Excelart P3 / Excelart SPIN & Excelart Vantagae, Recall # Z-0986-05
REASON
Patient information A is displayed with images of patient B.
CODE
All codes
RECALLING FIRM
Recalling Firm: Toshiba American Med Systems, Inc, Tustin, CA, by letter on May 25, 2005. Technicians will correct the software by visit beginning on May 25, 2005. Manufacturer: Matsushita Communication Industrial Co., Ltd, Hanishina-Gun, Japan. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
103 units
DISTRIBUTION
Nationwide
