Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report: 6/04/03
Class: III
PRODUCT
a) Acuson Diagnostic Ultrasound System Transducer; Model Number(s):
L582 Linear Array Transducer for use on the 128XP Ultrasound
System; Catalog Numbers: 23656 (New), 45441 (Refurb).
Recall # Z-0864-03;
b) Acuson Diagnostic Ultrasound System Transducer; Model Number(s):
L582 Linear Array Transducer for use on the 128XP Ultrasound
System; Catalog Numbers: 23656 (New), 45441 (Refurb).
Recall # Z-0865-03;
REASON
The product has a software condition in that the surface temperature of the transducer may reach above the thermal limit.
CODE
All Serial Numbers: XXXXXXXX (8-digit).
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by letters on March 24, 2003. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
220 units.
DISTRIBUTION
Nationwide, and Internationally.
