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U.S. Department of Health and Human Services

Class 2 Device Recall Hoana LifeBed

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 Class 2 Recall
Hoana LifeBed
see related information
Date Posted January 24, 2008
Recall Status1 Terminated on February 01, 2008
Recall Number Z-0592-2008
Recall Event ID 46154
Product Classification Monitor, Bed Patient - 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, Hawaii 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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.