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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.

FDA Recall Z-0738-2012 · Posted 2012-01-13

Recalling FirmLinet Americas Inc
Recall StatusTerminated
Product CodeFNL
Date Initiated2011-12-08
Date Terminated2012-07-20
Product Quantity29,252 units

Reason for Recall

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

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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