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U.S. Department of Health and Human Services

Class 2 Device Recall ECATS 2000 Safety Net Enclosure Medical Bed

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  Class 2 Device Recall ECATS 2000 Safety Net Enclosure Medical Bed see related information
Date Initiated by Firm April 05, 2006
Date Posted October 14, 2006
Recall Status1 Terminated 3 on September 21, 2012
Recall Number Z-0026-2007
Recall Event ID 36125
Product Classification BED - Product Code FNL
Product ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed
Code Information Serial Numbers: E9084 - E9094 & E10001 - E10099. The serial # is found at the bottom of the stick on label. The label is affixed to the foot of the bed frame on the right hand side.
Recalling Firm/
Manufacturer
Extended Care Air Therapy Systems Inc
7165 Payne Rd
Roseville OH 43777-9711
For Additional Information Contact Jerry May
800-374-0970
Manufacturer Reason
for Recall
Component defect- Following assembly and distribution, two (2) bolts may bend in the bed frame, which may allow the bed to tip into the wall
FDA Determined
Cause 2
Other
Action The firm sent a Product Advisory Letter to their distributor/customers on 4/5/2006. The letter instructs the distributors as to the correct way to handle the beds during movement, loading, and unloading onto delivery trucks. The letter also urges the distributors to inspect the bed frame units in inventory at their locations for the presence of any bending, or damage to the four frame bolts. The letter states that the company will replace the bolts as soon as possible when ever necessary.
Quantity in Commerce 102 beds
Distribution The recalled medical beds were distributed to six (6) wholesale/distributor customers located in the following states: KS, TN, MI, PA, and LA.
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.
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