Hoana Medical 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Hoana Medical
Lot Codes / Batch Numbers
All Serial Numbers
Products Sold
All Serial Numbers
Hoana Medical is recalling Hoana LifeBed Patient Vigilance System, (Intelligent Medical Vigilance System),Model Number: 010135- due to Bed Exit Failure: Failure to recognize "Bed Exit" when the feature is active due to a software anomaly.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Bed Exit Failure: Failure to recognize "Bed Exit" when the feature is active due to a software anomaly.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026