Atlas FDA

Clinitron At Home Air Fluidized Therapy Bed

FDA device recall Z-1555-05 · posted 2005-09-21 · Terminated

Recall details

Recalling firm
Hill-Rom Manufacturing, Inc.
Reason for recall
Sudden unexpected lowering of the head of the bed may occur due to failure of the had of the bed actuator.
Action taken
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
Status
Terminated
Product code
FNL
Quantity affected
21 beds
Distribution
AL, FL, KY, LA, MA, NC, NY, TN, TX, VA
Date initiated
2005-05-20
Date posted
2005-09-21
Date terminated
2006-04-26
Location
Charleston, SC

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Related 510(k) clearances

RecordFirmDate
CLINITRON AT HOME AIR FLUIDED THERAPY (K942184)Ssi Medical Services, Inc.1995-02-07