Inc Class III Siemans Medial Solutions USA

Company: Siemans Medial Solutions USA, Inc Co
Date of Enforcement Report: 3/31/04
Class: III

PRODUCT
Acuson Cypress Echocardiography System. Catalog number 8264604; Recall # Z-0744-04.

REASON
Software problem – mode does not appear on screen.

CODE
Serial numbers 73480 through 73535, 71165, 71561, 72532, 73125, and 73292.

RECALLING FIRM/MANUFACTURER
Siemans Medial Solutions USA, Inc, Plymouth Meeting, PA, by telephone from February 22/16, 2004. Firm initiated recall in ongoing.

VOLUME OF PRODUCT IN COMMERCE
46 units.

DISTRIBUTION
Nationwide and Internationally.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.