Philips Ultrasound, Inc: Medical Device Recall in 2025 - (Recall #: Z-2054-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.
Product Description:

Philips L12-3 Transducer.

Product Classification:

Class II

Date Initiated: May 28, 2025
Date Posted: July 9, 2025
Recall Number: Z-2054-2025
Event ID: 96994
Reason for Recall:

Ultrasound transducer devices were refurbished beyond their useful life.

Status: Ongoing
Product Quantity: 5,230 units
Code Information:

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.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated