Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning system
Recall
- Recall Number
- Z-1859-2025
- Event Number
- 96655
- Firm
- Ultra Clean Systems, Inc.
- FEI Number
- 3002811406
- Product Code
- FLG
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- March 31, 2025
- Posted
- May 28, 2025
- Address
- 110 Douglas Rd E, Oldsmar, FL, 34677-2910
Description
Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning system
During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation.
On 03/31/2025, the firm sent an "URGENT MEDICAL DEVICE CORRECTION" Letter via FedEx to customers informing them that as a result of an investigation, it has been revealed that a combination of chemical and electrical interactions that result in electrochemical degradation, compromising the structural integrity of the sensor over time. This degradation could potentially lead to water leakage into the machine. On 04/25/2025, the firm sent via FedEx and updated letter. Customers are notified and/or instructed that/to: -A field technicians will be contacting you to arrange for replacement if your unit has been impacted by this issue. -Complete and sign the attached response form to acknowledge that they have received the notification. Return the completed form to Getinge by emailing a scanned copy to [email protected] Public contact for questions/assistance - [email protected]
Worldwide - U.S. Nationwide distribution including in the states of AZ, CA, CO, FL, ID, IL, IN, KS, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OR, PA, SD, TX, VA, WA, WI, and WY. The country of Canada.
96 systems