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U.S. Department of Health and Human Services

Class 2 Device Recall Clinitron At Home Air Fluidized Therapy Bed

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  Class 2 Device Recall Clinitron At Home Air Fluidized Therapy Bed see related information
Date Initiated by Firm May 20, 2005
Date Posted September 21, 2005
Recall Status1 Terminated 3 on April 26, 2006
Recall Number Z-1555-05
Recall Event ID 32236
510(K)Number K942184  
Product Classification Bed, Ac-Powered Adjustable Hospital - Product Code FNL
Product Clinitron At Home Air Fluidized Therapy Bed
Code Information Serial numbers: CS102304, CS103257, CS103901, CS103902, CS103903, CS103904, CS103909, CS103911, CS103914, CS103915, CS103916, CS103917, CS103919, CS103921, CS103923, CS103924, CS103925, CS103928, CS103932, CS103933.
Recalling Firm/
Manufacturer		 Hill-Rom Manufacturing, Inc.
4349 Corporate Rd
Charleston SC 29405-7445
For Additional Information Contact Mark Lanning
843-740-8586
Manufacturer Reason
for Recall		 Sudden unexpected lowering of the head of the bed may occur due to failure of the had of the bed actuator.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 21 beds
Distribution AL, FL, KY, LA, MA, NC, NY, TN, TX, VA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FNL and Original Applicant = SSI MEDICAL SERVICES, INC.
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