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Terminated

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

FDA Recall Z-0592-2008 · Posted 2008-01-24

Recalling FirmHoana Medical
Recall StatusTerminated
Product CodeKMI
Date Initiated2007-11-07
Date Terminated2008-02-01
Product Quantity216 units

Reason for Recall

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

Firm 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.

Root Cause

Software design

Distribution Pattern

Nationwide including states of HI, CA, TX and MA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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