Recall Z-2393-2010 ยท FNL Bed, Ac-Powered Adjustable Hospital
Invacare Corporation
Invacare AC-Powered Adjustable Hospital Bed. Model 5890 IVC and 5490 IVC. Manufactured by: Invacare Corp. 2101 East Lake Mary Blvd., Sanford, FL 32773.
| Date | Sep 9, 2010 (initiated Oct 16, 2006) |
| Status | Terminated |
| Reason | Invacare Corporation, Florida issued a device correction in October 2006 for the IVC Bed Foot Actuator used on the IVC Bed Series, Models 5890 IVC and 5490 IVC. The actuators were not in the fully extended position and could not be mounted onto the beds. All affected consignees were notified of this correction in October 2006. |
| Root cause | Nonconforming Material/Component |
| Action | Invacare Corporation issued a notice of an Urgent Field Correction to Consignees on 10/18/2006. Consignees were instructed to check the serial number of their units to see if they were potentially affected. If so, the firm provided inspection and adjustment instructions of the foot actuator to prevent a likelihood of injury. After adjustment, the consignees were requested to complete and return the enclosed tracking sheet acknowledging receipt of the recall notice and correction of the bed(s). For questions or assistance regarding this correction, please contact the Customer Relationship |
| Quantity | 731 |
| Distribution | Product was distributed throughout the U.S. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.