Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning system
This recall is currently active, issued May 28, 2025. It was issued by Ultra Clean Systems, Inc..
- Company
- Ultra Clean Systems, Inc.
- Recall Initiated
- March 31, 2025
- Posted
- May 28, 2025
- Recall Number
- Z-1859-2025
- Quantity
- 96 systems
- Firm Location
- Oldsmar, FL
- Official Source
- View on FDA website ↗
Reason for Recall
During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation.
Distribution
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.
Lot / Code Info
Triton 36 Model Number 6003000804 UDI-DI code: 00816634020013 Serial Numbers: 1601-XL36-249-1 1604-XL36-277-1 1808-XL36TR-596-1 1810-XL36TR-618-1 1905-XL36TR-707-1 1907-XL36TR-721-1 1911-XL36TR-800-1 2001-XL36TR-834-1 2004-XL36TR-859-1 2004-XL36TR-873-1 2104-XL36TR-947-1 2201-XL36TR-001-1 2203-XL36TR-017-1 2306-XL36TR-050-1 2306-XL36TR-051-1 2307-XL36TR-053-1 2312-XL36TR-120-1 2401-XL36TR-001-1 2402-XL36TR-017-1 2402-XL36TR-018-1 2402-XL36TR-027-1 2402-XL36TR-028-1 2402-XL36TR-029-1 2402-XL36TR-030-1 2405-XL36TR-048-1 2405-XL36TR-049-1 2405-XL36TR-050-1 2405-XL36TR-051-1 2405-XL36TR-060-1 2405-XL36TR-061-1 2405-XL36TR-062-1 2405-XL36TR-063-1 2406-XL36TR-064-1 2406-XL36TR-065-1 2406-XL36TR-072-1 2406-XL36TR-074-1 2406-XL36TR-075-1 2407-XL36TR-079-1 2407-XL36TR-083-1 2409-XL36TR-101-1 2409-XL36TR-103-1 2409-XL36TR-105-1 2409-XL36TR-107-1 2409-XL36TR-109-1 2409-XL36TR-110-1 2410-XL36TR-111-1 2410-XL36TR-113-1 2410-XL36TR-114-1 2411-XL36TR-118-1 2411-XL36TR-122-1 2412-XL36TR-135-1 XL36TR4381 XL36TR4961 XL36TR5111 2307-XL36TR-055-1 Triton 72 Model Number 6003000805 UDI-DI code: 00816634020006 Serial Numbers: 1511-XL72-230-1 1606-XL72-291-1 1706-XL72TR-401-1 1805-XL72TR-544-1 1805-XL72TR-546-1 1806-XL72TR-564-1 1806-XL72TR-565-1 1807-XL72TR-568-1 1809-XL72TR-611-1 1910-XL72TR-788-1 2002-XL72TR-844-1 2004-XL72TR-878-1 2004-XL72TR-879-1 2005-XL72TR-881-1 2006-XL72TR-890-1 2103-XL72TR-929-1 2103-XL72TR-930-1 2104-XL72TR-946-1 2112-XL72TR-1022-1 2202-XL72TR-013-1 2202-XL72TR-014-1 2202-XL72TR-015-1 2203-XL72TR-016-1 2207-XL72TR-045-1 2211-XL72TR-088-1 2304-XL72TR-028-1 2305-XL72TR-030-1 2305-XL72TR-034-1 2309-XL72TR-073-1 2310-XL72TR-099-1 2402-XL72TR-023-1 2402-XL72TR-024-1 2404-XL72TR-047-1 2405-XL72TR-052-1 2405-XL72TR-053-1 2406-XL72TR-073-1 2407-XL72TR-080-1 2407-XL72TR-084-1 2409-XL72TR-104-1 2411-XL72TR-120-1 XL72TR4401
Root Cause
Under Investigation by firm
Action Taken
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 recallresponses.qrc@getinge.com Public contact for questions/assistance - recalls.qrc@getinge.com