Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2393-2010

Invacare AC-Powered Adjustable Hospital Bed. Model 5890 IVC and 5490 IVC. Manufactured by: Invacare Corp...

Invacare GmbH / initiated 2006-10-16 / Terminated / root cause: manufacturing process

Invacare Corporation began a recall of Invacare AC-Powered Adjustable Hospital Bed. Model 5890 IVC and 5490 IVC. Manufactured by: Invacare Corp. 2101 East Lake Mary Blvd., Sanford, FL 32773 on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2393-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Invacare GmbH
Product
Invacare AC-Powered Adjustable Hospital Bed. Model 5890 IVC and 5490 IVC. Manufactured by: Invacare Corp. 2101 East Lake Mary Blvd., Sanford, FL 32773.
Product code
FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall
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 tag
manufacturing process
FDA 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 Management Group at (800) 333-6900, or via e-mail at [email protected].
Quantity in commerce
731
Distribution
Product was distributed throughout the U.S.
Product codes and lots
Models: 5890 and 5490