Sammons Preston Rolyan – Class III

Company: Sammons Preston Rolyan
Date of Enforcement Report: 9/14/05
Class:III

PRODUCT
TM-300 Traction System; an Rx software driven device used for patient traction, Product No. A501-009, Recall # Z-1444-05

REASON
The traction device may malfunction, producing oscillation and a jerking motion.

CODE
Serial numbers 1000 through 1207

RECALLING FIRM/MANUFACTURER
Recalling Firm: Sammons Preston Rolyan, Bolingbrook, IL, by letters dated July 13, 2005.
Manufacturer: ITO Co., Ltd, Inashiki-gun, Japan. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
208 units

DISTRIBUTION
Nationwide and Internationally

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.