FDA Device

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

Hazard

Bed Exit Failure: Failure to recognize "Bed Exit" when the feature is active due to a software anomaly.

What You Should Do

Remedy

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.

Products

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
UPC
All Serial Numbers

Units Affected

216 units