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.
This recall has been terminated (originally issued December 23, 2009).
- Company
- Micromedical Technologies, Inc
- Recall Initiated
- November 16, 2009
- Posted
- December 23, 2009
- Terminated
- April 18, 2011
- Recall Number
- Z-0563-2010
- Quantity
- 10 units
- Firm Location
- Chatham, IL
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution -- United States (New York and Pennsylvania), Canada, Egypt, Korea, Poland and South Africa.
Lot / Code Info
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.
Root Cause
Nonconforming Material/Component
Action Taken
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.