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.

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

Corporate Office

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