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Terminated

Clinitron At Home Air Fluidized Therapy Bed

FDA Recall Z-1555-05 · Posted 2005-09-21

Recalling FirmHill-Rom Manufacturing, Inc.
Recall StatusTerminated
Product CodeFNL
Date Initiated2005-05-20
Date Terminated2006-04-26
Product Quantity21 beds

Reason for Recall

Sudden unexpected lowering of the head of the bed may occur due to failure of the had of the bed actuator.

Firm Action

Customer letter was hand delivered to consignees by Hill-Rom Service Technicians 05/20/2005. The affected product will be corrected by replacement of the actuator with one from an unaffected lot.

Root Cause

Other

Distribution Pattern

AL, FL, KY, LA, MA, NC, NY, TN, TX, VA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K942184CLINITRON AT HOME AIR FLUIDED THERAPYSsi Medical Services, Inc. · 1995-02-07

Official Source

View FDA Recall →

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

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