Class 2 Device Recall Hoana LifeBed

• Date Initiated by Firm: November 07, 2007
• Date Posted: January 24, 2008
• Recall Status: Terminated on February 01, 2008
• Recall Number: Z-0592-2008
• Recall Event ID: 46154
• Product Classification: Bed-Patient Monitor - Product Code KMI
• Product: Hoana LifeBed Patient Vigilance System, (Intelligent Medical Vigilance System),Model Number: 010135-01, Product distributed by Hoana Medical, Inc., 828 Fort St. Mall, Suite 620, Honolulu, HI
• Code Information: All Serial Numbers
• FEI Number: 3005596882
• Recalling Firm/ Manufacturer: Hoana Medical; 828 Fort Street Mall Ste 620; Honolulu HI 96813-4314
• For Additional Information Contact: Nancy Gertlar, MS, MBA, RAC; 808-523-1225
• Manufacturer Reason for Recall: Bed Exit Failure: Failure to recognize "Bed Exit" when the feature is active due to a software anomaly.
• FDA Determined Cause: Software design
• Action: On 11/7/07, all consignees were notified via an untitled letter and on-site visit by the firm's sales representative, informing them of the affected product and providing instructions on the recall. The recalling firm will arrange for installation of a software fix at each consignee.
• Quantity in Commerce: 216 units
• Distribution: Nationwide including states of HI, CA, TX and MA
• 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.