DadeMicroscan Pediatric Therapy Software Class II

REASON

Potential for incorrect Pediatric Reports–A software problem.

PRODUCT

a) 2-way MainFrame Interface Software Version 22.20;

b) Pediatric Therapy Guide Version 4.10.

Recall #Z-405/406-0.

CODE

Part Numbers: 9800-2666 and 9800-0630;

Catalog Numbers: B1018-15 and B1011-30.

MANUFACTURER

Dade Microscan Inc., West Sacramento, California.

RECALLED BY

Manufacturer, by letter on February 4, 2000. Firm-initiated field correction ongoing.

DISTRIBUTION

Nationwide and international.

QUANTITY

90 copies were distributed.

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.