A Division of Tyco Healthcare ClassII Radionics

Company: Radionics, A Division of Tyco Healthcare
Date of Enforcement Report: 11/21/01
Class: II

PRODUCT
Radionics XKnife RT Software, Recall # Z-0275-2.

REASON
Software error may cause incorrect jaw settings for a record/verify system.

CODE
Version 1.02 and lower.

RECALLING FIRM/ MANFACTURER
Radionics, A Division of Tyco Healthcare, Billerica, MA, by telephonebetween 9/17/2001 and 18/01. Firm initiated recall is ongoing.

PRODUCT
51.

DISTRIBUTION
Nationwide and International.

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.