Z-0174-04
Invacare IVC Home Care Bed (Foot Section with new head actuator from Linak
Invacare GmbH / initiated 2003-06-09 / Terminated
Invacare Corporation began a recall of Invacare IVC Home Care Bed (Foot Section with new head actuator from Linak on . The reason FDA records is "Pull tube on bed may bend or separate causing inoperability of bed or head section to fall". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0174-04
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Invacare GmbH
- Product
- Invacare IVC Home Care Bed (Foot Section with new head actuator from Linak.
- Product code
- LLI Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
- Reason for recall
- Pull tube on bed may bend or separate causing inoperability of bed or head section to fall.
- FDA root cause
- Other
- Action
- The firm began telephoning direct consignees on 6/9/03 and also began sending recall letters to these consignees on 6/9/03. The letter provides a list of affected units shipped to the consignee and the serial number of the affected foot section on the bed. If the consignee indicated they wanted to perform the correction themselves then the indicated number of corrective bracket installation kits are being sent. Also they are given the option of having an Invacare authorized service center perform the correction. This is for units in their possession and also at patient homes. As of October 2003 enough corrective kits have been forwarded to dealers to correct all involved units.
- Quantity in commerce
- 5926
- Distribution
- involved products were distributed to approximately 1100 dealers in the United Stated and to 54 Canadian dealer accounts.
- Product codes and lots
- Foot section model numbers and serial number ranges: Model # Beginning S/N Ending S/N 5490IVC 03D891256 03E035155 5890IVC 03D889942 03E002241 5491IVC 03E969254 03E433379 5891IVC 03E970154 03E971163 Bed Models that include the recalled food sections: 5310IVC, 5311IVC, 5410IVC, 5411IVC Bed package model numbers which include the affected Beds and foot sections: BED-21VC, BED-4IVC, BED-9IVC, BED-10IVC, BED-19IVC, BED-21IVC, BED-22IVC, BED-23IVC, BED-24IVC, BED-25IVC, BED-26IVC, BED-27IVC, BED-28IVC, BED-29IVC, BED-32IVC, BED-33IVC, BED-34IVC, BED-35IVC, BED-36IVC, BED-37IVC, CBED-2IVC, CBED-4IVC, CBED-4BIVC, CBED-11IVC, CBED-11BIVC, CBED-12IVC, CBED-12BIVC, CBED-19IVC, CBED-22IVC, CBED-23IVC, CBED-26IVC, CBED-28IVC.
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