Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning system
FDA Recall Z-1859-2025 · Posted 2025-05-28
Advertisement
Recalling FirmUltra Clean Systems, Inc.
Recall StatusOpen, Classified
Product CodeFLG
Date Initiated2025-03-31
Product Quantity96 systems
Reason for Recall
During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation.
Firm Action
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]
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement