| Class 2 Device Recall Hoana LifeBed | |
Date Initiated by Firm | November 07, 2007 |
Date Posted | January 24, 2008 |
Recall Status1 |
Terminated 3 on February 01, 2008 |
Recall Number | Z-0592-2008 |
Recall Event ID |
46154 |
Product Classification |
Bed-Patient Monitor - Product Code KMI
|
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 |
Code Information |
All Serial Numbers |
Recalling Firm/ Manufacturer |
Hoana Medical 828 Fort Street Mall Ste 620 Honolulu HI 96813-4314
|
For Additional Information Contact | Nancy Gertlar, MS, MBA, RAC 808-523-1225 |
Manufacturer Reason for Recall | Bed Exit Failure: Failure to recognize "Bed Exit" when the feature is active due to a software anomaly. |
FDA Determined Cause 2 | 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 |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
|
|
|