Class 2 Device Recall

• Date Initiated by Firm: September 16, 2005
• Date Posted: December 23, 2005
• Recall Status: Terminated on July 11, 2012
• Recall Number: Z-0305-06
• Recall Event ID: 33936
• 510(K)Number: K033030
• Product Classification: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) - Product Code MWI
• Product: Product is a CALYSTO Series IV Physio-monitoring & Information System model # M-S0053.
• Code Information: Serial numbers 970424D to 200501499.
• Recalling Firm/ Manufacturer: Witt Biomedical Corporation; 305 North Drive; Melbourne FL 32934-9201
• Manufacturer Reason for Recall: Customer complained that a boom monitor came off the boom. No patient or user injury was associated with the incident.
• FDA Determined Cause: Other
• Action: Consignees will be notified of recall by phone, the firm will use a phone script.
• Quantity in Commerce: 1541
• Distribution: Products were distributed to approximately 672 medical facilities throughout the United States.
• 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 = MWI and Original Applicant = WITT BIOMEDICAL CORP