Linet Remote Handset for model Multicare, Eleganza 3 and Eleganza Smart, hospital bed. Product Usage: Positional hospita

FDA device recall Z-0738-2012 · posted 2012-01-13 · Terminated

Recall details

Recalling firm

Linet Americas Inc

Reason for recall

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

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FNL

Quantity affected

29,252 units

Distribution

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

Date initiated

2011-12-08

Date posted

2012-01-13

Date terminated

2012-07-20

Location

Charlotte, NC