FDA Recall Terminated

Invacare AC-Powered Adjustable Hospital Bed. Model 5890 IVC and 5490 IVC. Manufactured by: Invacare Corp. 2101 East Lake Mary Blvd., Sanford, FL 32773.

Recall: Z-2393-2010 · Initiated October 16, 2006

Recall

Recall Number
Z-2393-2010
Event Number
56333
Firm
Invacare Corporation
FEI Number
1031452
Product Code
FNL
Status
Terminated
Root Cause
Nonconforming Material/Component
Initiated
October 16, 2006
Posted
September 9, 2010
Terminated
September 13, 2010
Address
2101 E. Lake Mary Blvd., Sanford, FL, 32773

Description

Invacare AC-Powered Adjustable Hospital Bed. Model 5890 IVC and 5490 IVC. Manufactured by: Invacare Corp. 2101 East Lake Mary Blvd., Sanford, FL 32773.

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.

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 Management Group at (800) 333-6900, or via e-mail at [email protected].

Distribution

Product was distributed throughout the U.S.

Quantity

731