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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Recall
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Date Posted September 09, 2010
Recall Status1 Terminated on September 13, 2010
Recall Number Z-2393-2010
Recall Event ID 56333
Product Classification Bed, Ac-Powered Adjustable Hospital - Product Code FNL
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.
Code Information Models: 5890 and 5490
Recalling Firm/
Manufacturer
Invacare Corporation
2101 E. Lake Mary Blvd.
Sanford, Florida 32773
Manufacturer 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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 CRMGroup@Invacare.com.
Quantity in Commerce 731
Distribution Product was distributed throughout the U.S.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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