Transducer L12-3 recallZ-2054-2025 · Philips Ultrasound, Inc · initiated May 28, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips Ultrasound, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Ultrasound transducer devices were refurbished beyond their useful life.
FDA root cause category: Process control
What the company is doing
An URGENT Medical Device Recall notification dated 5/28/25 was mailed to consignees. The notification informs consignees that Philips Ultrasound will be replacing transducers that were refurbished beyond their useful life with a new transducer. Consignees may continue to use affected devices while awaiting replacement; consignees should use devices in accordance with their intended use and per the instructions provided int he User Manual. Users should perform visual inspection and electrical safety testing as indicated in the User Manual; if a device does not pass inspection, it should be removed from clinical use. Consignees are asked to return the completed Response Form and circulate the provided notification to all users to ensure awareness. A copy of the recall notification should be kept with affected transducers until their replacement. Consignees with any questions can contact the Customer Care Solutions Center at 1-800-722-9377. Additional consignees were identified and notified via URGENT Medical Device Recall Notification on 9/5/25.
Recall details
- Recall number
- Z-2054-2025
- Status
- Open, Classified
- Initiated by the company
- May 28, 2025
- Posted by the FDA
- Jul 2, 2025
- Recalling firm
- Philips Ultrasound, Inc
- Quantity
- 5,230 units
- Product code
- ITX
- FDA submissions
- K043535, K123754, K081661, K091804, K111513
- Distribution
- Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, United Arab Emirates, Venezuela, Vietnam.
Product description
Philips L12-3 Transducer.
Code information (models, lots, serial numbers)
Show the full code information (4k characters)
Model No.989605412072, 989605412071, 989605438571, 989605348241; UDI: (01)00884838061620(21)B0TLJT, (01)00884838061620(21)B10GRD, (01)00884838061620(21)B0PYG5, (01)00884838061620(21)B0HF63, (01)00884838061620(21)B0WMR0, (01)00884838061620(21)B15HGH, (01)00884838061620(21)B0Q3CK, (01)00884838061620(21)B0K211, (01)00884838061620(21)B138Y9, (01)00884838061620(21)B11C62, (01)00884838061620(21)B0NK8H, (01)00884838061620(21)B1396N, (01)00884838061620(21)B139FV, (01)00884838061620(21)B0PY5N, (01)00884838061620(21)B16XQR, (01)00884838061620(21)B126FZ, (01)00884838061620(21)B18R5Q, (01)00884838061620(21)B0QKNF, (01)00884838061620(21)B0R3XG, (01)00884838061620(21)B0QN7N, (01)00884838061620(21)B14ZY4, (01)00884838061620(21)B18R9K, (01)00884838061620(21)B1500H, (01)00884838061620(21)B1KB6Q, (01)00884838061620(21)B15NHL, (01)00884838061620(21)B170P0, (01)00884838061620(21)B1CPKD, (01)00884838061620(21)B0TKYJ, (01)00884838061620(21)B144FW, (01)00884838061620(21)B10QGD, (01)00884838061620(21)B13W02, (01)00884838061620(21)B126J4, (01)00884838061620(21)B14ZY0, (01)00884838061620(21)B1B5CB, (01)00884838061620(21)B0PYKQ, (01)00884838061620(21)B1507L, (01)00884838061620(21)B0NKBB, (01)00884838061620(21)B0QN14, (01)00884838061620(21)B10H8J, (01)00884838061620(21)B1410P, (01)00884838061620(21)B12N2J, (01)00884838061620(21)B12P39, (01)00884838061620(21)B16XG6, (01)00884838061620(21)B1503X, (01)00884838061620(21)B0QVTZ, (01)00884838061620(21)B11C3C, (01)00884838061620(21)B15NHC, (01)00884838061620(21)B0TLRJ, (01)00884838061620(21)B126DT, (01)00884838061620(21)B0TJ3R, (01)00884838061620(21)B0TLJD, (01)00884838061620(21)B10H24, (01)00884838061620(21)B139CM, (01)00884838061620(21)B10HHN, (01)00884838061620(21)B0KD06, (01)00884838061620(21)B167H9, (01)00884838061620(21)B139D9, (01)00884838061620(21)B0PY4C, (01)00884838061620(21)B1DV9P, (01)00884838061620(21)B10H55, (01)00884838061620(21)B0QN1W, (01)00884838061620(21)B12MR6, (01)00884838061620(21)B13WBQ, (01)00884838061620(21)B13TVQ, (01)00884838061620(21)B0QVR8, (01)00884838061620(21)B12PCN, (01)00884838061620(21)B1B50V, (01)00884838061620(21)B0X653, (01)00884838061620(21)B0TKXK, (01)00884838061620(21)B10QB6, (01)00884838061620(21)B0HDZM, (01)00884838061620(21)B0HF5T, (01)00884838061620(21)B13W6K, (01)00884838061620(21)B13TYP, (01)00884838061620(21)B10HRP, (01)00884838061620(21)B15NBJ, (01)00884838061620(21)B0KDC1, (01)00884838061620(21)B12MYR, (01)00884838061620(21)B11CJ4, (01)00884838061620(21)B17Z4R, (01)00884838061620(21)B12PMW, (01)00884838061620(21)B14ZZH, (01)00884838061620(21)B0L6TT, (01)00884838061620(21)B0Q3FN, (01)00884838061620(21)B10H1W, (01)00884838061620(21)B0PYNJ, (01)00884838061620(21)B1B1VF, (01)00884838061620(21)B1VK09, (01)00884838061620(21)B0TKZK, (01)00884838061620(21)B15009, (01)00884838061620(21)B0WMM7, 010088483806162021B0L6WG, (01)00884838061620(21)B10GRJ, 010088483806162021B0K1TC, (01)00884838061620(21)B0TLJY, (01)00884838061620(21)B0KDC7, (01)00884838061620(21)B0KD20, (01)00884838061620(21)B0TL1Z, (01)00884838061620(21)B170X6, (01)00884838061620(21)B0QVYF, (01)00884838061620(21)B10H7Y, 010088483806162021B0TL2H, 010088483806162021B15HDW; Serial No. Serial Number, B0TLJT, B10GRD, B0PYG5, B0HF63, B0WMR0, B15HGH, B0Q3CK, B0K211, B138Y9, B11C62, B0NK8H, B1396N, B139FV, B0PY5N, B16XQR, B126FZ, B18R5Q, B0QKNF, B0R3XG, B0QN7N, B14ZY4, B18R9K, B1500H, B0QN1T, B1KB6Q, B15NHL, B170P0, B1CPKD, B0TKYJ, B144FW, B10QGD, B13W02, B126J4, B14ZY0, B1B5CB, B0PYKQ, B1507L, B0NKBB, B0QN14, B10H8J, B1410P, B12N2J, B12P39, B16XG6, B1503X, B0QVTZ, B11C3C, B15NHC, 03F23Y, B0TLRJ, B126DT, B0TJ3R, B0TLJD, B10H24, B139CM, B10HHN, B0KD06, B167H9, B139D9, B0PY4C, B1DV9P, B10H55, B0QN1W, B12MR6, B13WBQ, B13TVQ, B0QVR8, B12PCN, B13VX5, B1B50V, B0X653, B0TKXK, B10QB6, B0HDZM, B0HF5T, B13W6K, B13TYP, B10HRP, B15NBJ, B0KDC1, B12MYR, B11CJ4, B17Z4R, B12PMW, B14ZZH, B0L6TT, B0Q3FN, B10H1W, B0PYNJ, B1B1VF, B144D8, B1VK09, B0TKZK, 03F6Z6, B15009, B0WMM7, B0L6WG, B10GRJ, B0K1TC, B0TLJY, B0KDC7, B12MMB, B0K1T6, B126FG, B0KD20, B0TL1Z, B170X6, 02Q8L8, B0QVYF, B10H7Y, B0TL2H, B15HDW.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Transducer L12-3 989605412072Philips Ultrasound LLC · Transducer, ultrasonic, diagnostic5 recalls1 report
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 96994).
- Z-2048-2025 · Open, ClassifiedPhilips 3D9-3v Transducer.
- Z-2049-2025 · Open, ClassifiedPhilips C5-1 Transducer.
- Z-2050-2025 · Open, ClassifiedPhilips C5-2 Transducer.
- Z-2052-2025 · Open, ClassifiedPhilips eL18-4 Transducer.
- Z-2053-2025 · Open, ClassifiedPhilips eL18-4 EMT Transducer.
- Z-2055-2025 · Open, ClassifiedPhilips L12-4 Transducer.
- Z-2056-2025 · Open, ClassifiedPhilips L8-4 Transducer.
- Z-2058-2025 · Open, ClassifiedPhilips S5-1 Transducer.
- Z-2059-2025 · Open, ClassifiedPhilips S7-2 Transducer.
- Z-2060-2025 · Open, ClassifiedPhilips S7-3t Transducer.
- Z-2061-2025 · Open, ClassifiedPhilips S8-3t Transducer.
- Z-2062-2025 · Open, ClassifiedPhilips V6-2 Transducer.
- Z-2063-2025 · Open, ClassifiedPhilips VL13-5 Transducer.
- Z-2064-2025 · Open, ClassifiedPhilips X5-1 Transducer.
- Z-2065-2025 · Open, ClassifiedPhilips X6-1 Transducer.
- Z-2066-2025 · Open, ClassifiedPhilips X7-2t Transducer.
- Z-2067-2025 · Open, ClassifiedPhilips X8-2t Transducer.
- Z-2068-2025 · Open, ClassifiedPhilips XL14-3 Transducer.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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