FDA Medical Device Recalls (openFDA)
Micromedical Technologies, Inc: 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.
- Recall number
- Z-0563-2010
- Recalling firm
- Micromedical Technologies, Inc
- 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.
- Status
- Terminated
- Initiated
- 2009-11-16
- Posted
- 2009-12-23
- Terminated
- 2011-04-18
- Reason
- 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.
- Root cause
- 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
- 10 units
- Distribution
- Worldwide Distribution -- United States (New York and Pennsylvania), Canada, Egypt, Korea, Poland and South Africa.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ETP
- Firm FEI
- 1450721
- Firm city
- Chatham
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28