FDA Recall
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
Recall: Z-0592-2008
·
Initiated November 7, 2007
Recall
- Recall Number
- Z-0592-2008
- Event Number
- 46154
- Firm
- Hoana Medical
- FEI Number
- 3005596882
- Product Code
- KMI
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- November 7, 2007
- Posted
- January 24, 2008
- Terminated
- February 1, 2008
- Address
- 828 Fort Street Mall, Ste 620, Honolulu, HI, 96813-4314
Description
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.
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.
Distribution
Nationwide including states of HI, CA, TX and MA
Quantity
216 units