Z-0592-2008

Hoana LifeBed Patient Vigilance System, (Intelligent Medical Vigilance System),Model Number: 010135-01...

Name: Z-0592-2008 Hoana LifeBed Patient Vigilance System, (Intelligent Medical Vigilance System),Model Number: 010135-01...
Creator: Hoana Medical
Published: 2007-11-07
License: https://open.fda.gov/license/

Hoana Medical, Inc. / initiated 2007-11-07 / Terminated / root cause: software

FDA source

Hoana Medical began a recall of Hoana LifeBed Patient Vigilance System, (Intelligent Medical Vigilance System),Model Number: 010135-01, Product distributed by Hoana Medical, Inc., 828 Fort... on 2007-11-07. The reason FDA records is "Bed Exit Failure: Failure to recognize "Bed Exit" when the feature is active due to a software anomaly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0592-2008
Status: Terminated
Initiated: 2007-11-07
Posted: 2008-01-24
Terminated: 2008-02-01
Recalling firm: Hoana Medical, Inc.
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
Product code: KMI Monitor, Bed Patient
Reason for recall: Bed Exit Failure: Failure to recognize "Bed Exit" when the feature is active due to a software anomaly.
Root cause tag: software
FDA root cause: 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
Product codes and lots: All Serial Numbers

Product code KMI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)