FDA Medical Device Recalls (openFDA)
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 number
- Z-0592-2008
- Recalling firm
- 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
- Status
- Terminated
- Initiated
- 2007-11-07
- Posted
- 2008-01-24
- Terminated
- 2008-02-01
- Reason
- Bed Exit Failure: Failure to recognize "Bed Exit" when the feature is active due to a software anomaly.
- 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
- 216 units
- Distribution
- Nationwide including states of HI, CA, TX and MA
- Lot, serial or model codes
- All Serial Numbers
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KMI
- Firm FEI
- 3005596882
- Firm city
- Honolulu
- Firm state
- HI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28