Recall Z-0563-2010 ยท ETP Stimulator, Caloric-Water
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 t
| Date | Dec 23, 2009 (initiated Nov 16, 2009) |
| Status | Terminated |
| 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 t |
| Quantity | 10 units |
| Distribution | Worldwide Distribution -- United States (New York and Pennsylvania), Canada, Egypt, Korea, Poland and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.