Recall Z-0592-2008 ยท KMI Monitor, Bed Patient
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
| Date | Jan 24, 2008 (initiated Nov 7, 2007) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.