NeuroCybernetic Prostheses Software Class II

PRODUCT

Model 250 NeuroCybernetic Prostheses (NCP) Programming Software Versions

a) 4/1;

b) 4.4, implanted autonomic nerve stimulator for he treatment of
epilepsy.

REASON

The label insert sheets were printed with the incorrect lot number.

CODE

Lot numbers a) 23952C; b) 26023C, 27137C, 27735C.

Recall #Z-570/571-0.

MANFACTURER

Cyberonics, Inc., Inc., Houston, Texas.

RECALLED BY

Manufacturer, by telephone and letter on August October 6, 1999. Firm-
initiated field correction complete.

DISTRIBUTION

a) Canada; b) Belgium and Europe.

QUANTITY

a) 1 unit of lot number 23952C; b) 10 units of lot number, 26023C, 10
units of lot 27137C and 50 units of lot 27735C 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.