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U.S. Department of Health and Human Services

Class 2 Device Recall Ultrasonic Cleaning Systems

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 Class 2 Device Recall Ultrasonic Cleaning Systemssee related information
Date Initiated by FirmMarch 31, 2025
Date PostedMay 28, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1859-2025
Recall Event ID 96655
Product Classification Cleaner, ultrasonic, medical instrument - Product Code FLG
ProductUltrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning system
Code Information 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
FEI Number 3002811406
Recalling Firm/
Manufacturer		 Ultra Clean Systems, Inc.
110 Douglas Rd E
Oldsmar FL 34677-2910
Manufacturer Reason
for Recall		During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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
Quantity in Commerce96 systems
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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