FDA Recall Terminated

Linet Remote Handset for model Multicare, Eleganza 3 and Eleganza Smart, hospital bed. Product Usage: Positional hospital bed for acute care. The bed is designed for the care and treatment of inpatients at hospitals and is designed for standard and intensive care.

Recall: Z-0738-2012 · Initiated December 8, 2011

Recall

Recall Number
Z-0738-2012
Event Number
60857
Firm
Linet Americas Inc
FEI Number
3008007426
Product Code
FNL
Status
Terminated
Root Cause
Nonconforming Material/Component
Initiated
December 8, 2011
Posted
January 13, 2012
Terminated
July 20, 2012
Address
10430 Harris Oak Blvd, Ste A, Charlotte, NC, 28269-7511

Description

Linet Remote Handset for model Multicare, Eleganza 3 and Eleganza Smart, hospital bed. Product Usage: Positional hospital bed for acute care. The bed is designed for the care and treatment of inpatients at hospitals and is designed for standard and intensive care.

Reason

The premature failure of the Remote Handset buttons may result in unintended movement of the bed.

Action

Linet sent a notification letter dated December 9, 2011 to all affected customers. The letter identified the product, problem, and actions to be taken. The letter states that firm Linet has decided to do a voluntary field correction to replace the recalled product. The replacement will be completed by the territory Representative (Linet Employee) who will replace the affected product for each customer personally. The replacement takes approximately 30 seconds and does not require the patient to be moved. For questions or concerns call 704-248-5650.

Distribution

Worldwide Distribution - USA (nationwide) including the states of: AL, FL, KY, LA, MA, NC, NY, OH and the country of: Canada

Quantity

29,252 units