Invacare IVC Home Care Bed (Foot Section with new head actuator from Linak.

FDA device recall Z-0174-04 · posted 2004-07-20 · Terminated

Recall details

Recalling firm

Invacare Corporation

Reason for recall

Pull tube on bed may bend or separate causing inoperability of bed or head section to fall.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

LLI

Quantity affected

5926

Distribution

involved products were distributed to approximately 1100 dealers in the United Stated and to 54 Canadian dealer accounts.

Date initiated

2003-06-09

Date posted

2004-07-20

Date terminated

2014-05-08

Location

Elyria, OH