#SIZEWISE BED CONTROL REPLACEMENT CODE#
Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55. 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. The beds were shipped to the nationwide customers of their one consignee who is located in KS.ġ A record in this database is created when a firm initiates a correction or removal action. The actuators were sent to their company stores and dealers in early March. The customer then notified their company stores and dealers via service bulletin dated 2/28/06 that they would be receiving new acutators for replacement on the beds.
The recalling firm met with their one customer on/about 11/14/05 explaining the reason for correction. The bed may drop due to a malfunction of the actuator exceeding its stop. The beds are distributed by SIZEWise Rentals, Ellis, KS. Low-Boy Bed, AC-powered adjustable hospital bed with a low position of 7'' to a high position of 30''. Class 2 Device Recall SIZEWise Rentals LowBoy Bedīed, Ac-Powered Adjustable Hospital - Product Code FNL
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