Cincinnati Sub-Zero Products Class II

Company: Cincinnati Sub-Zero Products
Date of Enforcement Report: 4/13/05
Class: II

PRODUCT
Micro-temp II heat therapy unit, model #747. Recall # Z-0671-05.

REASON
There is the potential that the power switch assembly can dislodge from the cabinet during use.

CODE
All units containing version 0.70 software.

RECALLING FIRM/MANUFACTURER
Cincinnati Sub-Zero Products, Cincinnati, OH, by letters dated January 18, 2005. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
553 devices.

DISTRIBUTION
Nationwide.

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.