Class 2 Device Recall Hamilton

• Date Initiated by Firm: May 24, 2006
• Date Posted: July 22, 2006
• Recall Status: Terminated on December 21, 2006
• Recall Number: Z-1251-06
• Recall Event ID: 35592
• 510(K)Number: K022679 K052863
• Product Classification: Ventilator - Product Code CBK
• Product: Hamilton brand RAPHAEL Color Ventilator (Software Vesion. 2.2xC, 2.2xCU)Product is distributed by Hamilton Medical, Inc., 4990 Energy Way, Reno, NV 89502
• Code Information: Serial Numbers 2975 to 5360
• Recalling Firm/ Manufacturer: Hamilton Medical Inc; 4990 Energy Way; P O Box 30008; Reno NV 89520-3008
• For Additional Information Contact: Arthur Gutzeit; 775-858-3200 Ext. 211
• Manufacturer Reason for Recall: ALARM FAILURE-Following an oxygen cell calibration, the user may inadvertently and unknowingly disable the alarm system.
• FDA Determined Cause: Other
• Action: On May 24, 2006 the manufacturer initiated this recall. The Recalling establishment/US Initial Importer/Distributor-received the manufacturer''s notice on May 31, 2006 and initiated their recall on June 1, 2006. The US distributor has issued a Medical Device Field Correction.
• Quantity in Commerce: 2,385 for all models
• Distribution: Worldwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CBK