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U.S. Department of Health and Human Services

Class 2 Device Recall Hoana LifeBed

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  Class 2 Device Recall Hoana LifeBed see related information
Date Initiated by Firm November 07, 2007
Date Posted January 24, 2008
Recall Status1 Terminated 3 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
Recalling Firm/
Hoana Medical
828 Fort Street Mall Ste 620
Honolulu HI 96813-4314
For Additional Information Contact Nancy Gertlar, MS, MBA, RAC
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 2
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.