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U.S. Department of Health and Human Services

Class 2 Device Recall FLEXICAIR II

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  Class 2 Device Recall FLEXICAIR II see related information
Date Initiated by Firm August 27, 2003
Date Posted October 24, 2003
Recall Status1 Terminated 3 on July 01, 2004
Recall Number Z-0058-04
Recall Event ID 27202
510(K)Number K863047  
Product Classification Bed, Flotation Therapy, Powered - Product Code IOQ
Product FLEXICAIR¿ II, Low Airloss Therapy unit.This unit is similar to MC3 but does not have the utility shelf above the foodboard, patient scale or alternate CPR function actuators.
Code Information Model #13000, IBxxxxxx (where xxxxxxx is a 6-digit number sequence)
Recalling Firm/
Manufacturer		 Hill-Rom Manufacturing, Inc.
4349 Corporate Road
Charleston SC 29405
For Additional Information Contact Mark Lanning
843-740-8586
Manufacturer Reason
for Recall		 Reports of patient entrapment between mattress and side-rails.
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter on 08/27/2003. They were alerted to the potential for patient entrapment. Modification of the units were to be conducted at the rental service center, or the sight where the unit is currently located. The consignee would be contacted to arrange for the modification to be installed on the rental if it is at their location when the modification is scheduled for the unit. If the consignee purchased the bed, they would be contacted by a Hill Rom service representative to arrange to install the modification.Enclosed with the letter is information regarding, Tips For Reducing the Risk of Patient Entrapment.
Quantity in Commerce 515 units
Distribution Product is distributed through rental and sale nationwide, Canada, Austria, Germany and the U.K.
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 = IOQ and Original Applicant = SSI MEDICAL SERVICES, INC.
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