Recall Z-0174-04 ยท LLI Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
Invacare Corporation
Invacare IVC Home Care Bed (Foot Section with new head actuator from Linak.
| Date | Jul 20, 2004 (initiated Jun 9, 2003) |
| Status | Terminated |
| Reason | Pull tube on bed may bend or separate causing inoperability of bed or head section to fall. |
| 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 |
| Quantity | 5926 |
| Distribution | involved products were distributed to approximately 1100 dealers in the United Stated and to 54 Canadian dealer accounts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.