Hoana LifeBed Patient Vigilance System…

Date posted by the FDA

Jan. 24, 2008

Status

Terminated

Filed by

Hoana Medical

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

Reason

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

Distribution pattern

Nationwide including states of HI, CA, TX and MA

Quantity

216 units

Codes and lots

All Serial Numbers

Recall started

Nov. 7, 2007

Device type

Monitor, Bed Patient

Root cause (FDA)

Software design

What the company told customers

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.

Recall number

Z-0592-2008

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0592-2008. The agency record governs; check it and the company before acting.