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U.S. Department of Health and Human Services

Class 3 Device Recall AquaStar

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  Class 3 Device Recall AquaStar see related information
Date Initiated by Firm November 16, 2009
Date Posted December 23, 2009
Recall Status1 Terminated 3 on April 18, 2011
Recall Number Z-0563-2010
Recall Event ID 53837
Product Classification Water Caloric Irrigator - Product Code ETP
Product AquaStar Water Caloric Irrigator; water caloric stimulator; Manufactured for/Distributed by Micromedical Technologies, Inc., 10 Kemp Drive, Chatham, IL 62629 USA, Instrumentation Difra, Made in Belgium.

The AquaStar water caloric irrigator delivers a precisely controlled temperature and flow rate of cool or warm water for vestibular stimulation during caloric testing. The caloric tests evaluate the viability of the horizontal semicircular canal by stimulating them with warm and cool water while the patient's eyes are closed. The resulting dizziness and nystagmus is taken as an index of the viability of the organ. The eyes are then opened to evaluate the ability of the CNS to visually suppress inappropriate dizziness and nystagmus.
Code Information Serial numbers: 1FX/17548/05,1GV/17548/01, 1GV/17548/02, 1GV/17548/03, 1GV/17548/04, 1GW/17549/01, 1GW/17549/02, 1GW/17549/07, 1GW/17549/08 and 1GW/17549/10.
Recalling Firm/
Manufacturer		 Micromedical Technologies, Inc
10 Kemp Dr
Chatham IL 62629
For Additional Information Contact Mr. Richard D. Miles
217-483-2122 Ext. 122
Manufacturer Reason
for Recall		 Some of the filters on both the display board and the main electronic board (PCB) become oxidized causing the LCD display to be garbled and the timer will not operate.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Micromedical Technologies, Inc. sent letters dated November 16, 2009 via e-mail (with read receipt) to each customer and their representative. If they did not have the customer's e-mail address, the sales representative was requested to forward the letter to the customer and copy Micromedical. The letters advised the customers that one or more electronic components in the AquaStar caloric irrigator may fail due to contact corrosion. In the event of this failure, unheated tap water will continue to flow through the device back to the water drain, but the LCD display will be garbled and the timer will not operate. If this problem develops, the account should stop using the irrigator and contact Micromedical Technologies, Inc. at 1-217-483-2122 or via e-mail at mmtinfo@micromedical.com to report the problem for repair of the unit.
Quantity in Commerce 10 units
Distribution Worldwide Distribution -- United States (New York and Pennsylvania), Canada, Egypt, Korea, Poland and South Africa.
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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