Philips Ultrasound, Inc: Philips C5-2 Transducer.

Recall number

Z-2050-2025

Recalling firm

Philips Ultrasound, Inc

Product

Philips C5-2 Transducer.

Status

Open, Classified

Initiated

2025-05-28

Posted

2025-07-02

Terminated

not on file

Reason

Ultrasound transducer devices were refurbished beyond their useful life.

Root cause

Process control

Action

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.

Quantity

5,230 units

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.

Lot, serial or model codes

Model No.989605389242, 989605454101, 989605398211, 989605450353, 989605451181, 989605477131, 989605450351, 989605450352; UDI: (01)00884838067424(21)B36LWB, (01)00884838067424(21)B2YZPM, (01)00884838067424(21)B34JQB, (01)00884838067424(21)F01L9N, (01)00884838067424(21)B3V8CH, (01)00884838067424(21)B3LJYB, (01)00884838067424(21)B2C4FQ, (01)00884838067424(21)F010MV, (01)00884838067424(21)B3VGXG, (01)00884838067424(21)F03968, (01)00884838067424(21)B31MT5, (01)00884838067424(21)B28T00, (01)00884838067424(21)B2C44Y, (01)00884838067424(21)B3D56M, (01)00884838067424(21)B22P69, (01)00884838067424(21)B3Q81Z, (01)00884838067424(21)B20145, (01)00884838067424(21)B3R9R3, (01)00884838067424(21)B3G9N5, (01)00884838067424(21)F0174Y, (01)00884838067424(21)B200TW, (01)00884838067424(21)B224WW, (01)00884838067424(21)B3C3W7, (01)00884838067424(21)B2JX46, (01)00884838067424(21)B2VM4B, (01)00884838067424(21)B30VBF, (01)00884838067424(21)B3WD3C, (01)00884838067424(21)B39XCG, (01)00884838067424(21)B2L1X5, (01)00884838067424(21)B2VLYK, (01)00884838067424(21)B3LZ50, (01)00884838067424(21)B3V9LJ, (01)00884838067424(21)B25N1F, (01)00884838067424(21)B231L5, (01)00884838067424(21)B31MT1, (01)00884838067424(21)B2C3W9, (01)00884838067424(21)F016D1, (01)00884838067424(21)B22NVD, (01)00884838067424(21)F008M1, (01)00884838067424(21)B1XBNC, (01)00884838067424(21)B30V7Y, (01)00884838067424(21)B34JXT, (01)00884838067424(21)B3QQX0, (01)00884838067424(21)B2JWTF, (01)00884838067424(21)B1Y1D9, (01)00884838067424(21)F02QD4, (01)00884838067424(21)B34T00, (01)00884838067424(21)F01K6Z, (01)00884838067424(21)B3P65C, (01)00884838067424(21)B224KM, (01)00884838067424(21)B33706, (01)00884838067424(21)B32B9T, (01)00884838067424(21)B2ND6N, (01)00884838067424(21)B39XDX, (01)00884838067424(21)B2WDTZ, (01)00884838067424(21)B2HNP4, (01)00884838067424(21)B2YZT6, (01)00884838067424(21)B30CJT, (01)00884838067424(21)B39ZX8, (01)00884838067424(21)B200T8, (01)00884838067424(21)B37D0B, (01)00884838067424(21)B2WZYX, (01)00884838067424(21)B2JXDC, (01)00884838067424(21)B2FY26, (01)00884838067424(21)B34MHH, (01)00884838067424(21)B2Q8W4, (01)00884838067424(21)B2XBFY, (01)00884838067424(21)B2L1W0, (01)00884838067424(21)B22P40, (01)00884838067424(21)B2C5P4, (01)00884838061385(21)B127JJ, (01)00884838061385(21)B11G3D, (01)00884838067424(21)B224KD, (01)00884838061385(21)B0JJLQ, (01)00884838061385(21)B0NG16, (01)00884838067424(21)F019T7, (01)00884838067424(21)B3H966, (01)00884838067424(21)F01GFM, (01)00884838067424(21)F0119H, (01)00884838067424(21)B39FB8, (01)00884838067424(21)F002CB, (01)00884838067424(21)B36B5B, (01)00884838067424(21)B23VFT, (01)00884838067424(21)F013HC, (01)00884838067424(21)B2R8T8, (01)00884838067424(21)B3G8ZY, (01)00884838067424(21)B2NDGV, (01)00884838067424(21)B37D8Y, (01)00884838067424(21)F005XT, (01)00884838067424(21)B2Y9YX, (01)00884838067424(21)B3RKBD, (01)00884838067424(21)B37D2W, (01)00884838067424(21)F02QD3, (01)00884838067424(21)B3V9NL, (01)00884838067424(21)B1XB2Q, (01)00884838067424(21)B2C43R, (01)00884838067424(21)B2L1T9, (01)00884838067424(21)B3Q81N, (01)00884838067424(21)B37D34, (01)00884838067424(21)B34JXC, (01)00884838067424(21)B3M9F3, (01)00884838067424(21)B2C5FL, (01)00884838067424(21)B35YBH, (01)00884838067424(21)B2M84V, (01)00884838067424(21)F004KL, (01)00884838067424(21)B3DQCW, (01)00884838067424(21)F02DPJ, (01)00884838067424(21)B2C40T, (01)00884838067424(21)B224RL, (01)00884838067424(21)B231GL, (01)00884838067424(21)B3VGXP, (01)00884838067424(21)B3RJXK, (01)00884838067424(21)B224JV, (01)00884838067424(21)F01C47, (01)00884838067424(21)B3VCQD, (01)00884838067424(21)B28RPC, (01)00884838067424(21)B3QR18, (01)00884838067424(21)F002CD, (01)00884838067424(21)B20170, (01)00884838067424(21)F00LD5, (01)00884838067424(21)B2C449, (01)00884838067424(21)B34T3Z, (01)00884838067424(21)B32B77, (01)00884838067424(21)B2YZXG, (01)00884838067424(21)B2M78R, (01)00884838067424(21)B2HN85, (01)00884838067424(21)B2YZQF, (01)00884838067424(21)B25M1W, (01)00884838067424(21)B38WW3, (01)00884838067424(21)B39XG1, (01)00884838067424(21)B2L1Y9, (01)00884838061385(21)B0T4G8, (01)00884838067424(21)B1XBJZ, (01)00884838061385(21)B0HNH9, (01)00884838061385(21)B0WNP3, (01)00884838061385(21)B12WHD, (01)00884838061385(21)B0QVLH, (01)00884838067424(21)B2BBKQ, (01)00884838067424(21)B28RNX, (01)00884838067424(21)B3M9CY, (01)00884838067424(21)B2JWX4, (01)00884838067424(21)B200R1, (01)00884838067424(21)B2VLNB, (01)00884838067424(21)B25N07, (01)00884838067424(21)B3VGZP, (01)00884838067424(21)B38WQ2, (01)00884838067424(21)B3RKB7, (01)00884838067424(21)B37DL7, (01)00884838067424(21)B34JQR, (01)00884838067424(21)B23W05, (01)00884838067424(21)B3V9FD, (01)00884838067424(21)F0103N, (01)00884838067424(21)F014WR, (01)00884838067424(21)B36LRF, (01)00884838067424(21)B35YFJ, (01)00884838067424(21)B307T7, (01)00884838067424(21)B31MQ3, (01)00884838067424(21)B3JQTT, (01)00884838067424(21)B1XB6C, (01)00884838067424(21)B3F4T5, (01)00884838067424(21)B39X4R, (01)00884838067424(21)B3C3PN, (01)00884838067424(21)B3F508, (01)00884838067424(21)B3VCQT, (01)00884838067424(21)F027KD, (01)00884838067424(21)B20156, (01)00884838067424(21)B3RB11, (01)00884838067424(21)F00LDG, (01)00884838067424(21)B2BBKL, (01)00884838067424(21)B3R49J, (01)00884838067424(21)F00PJ0, (01)00884838067424(21)B23W0X, (01)00884838067424(21)F016L9, (01)00884838067424(21)B2C42R, (01)00884838067424(21)B217CD, (01)00884838067424(21)B2NDNG, (01)00884838067424(21)B3F5DY, (01)00884838067424(21)B3V9JP, (01)00884838067424(21)B2HN60, (01)00884838067424(21)B22P38, (01)00884838067424(21)B2Z0NZ, (01)00884838067424(21)B27XBQ, (01)00884838067424(21)B2L1VZ, (01)00884838067424(21)B224QQ, (01)00884838067424(21)B2YZQC, (01)00884838067424(21)B200VX, (01)00884838067424(21)B2C4XN, (01)00884838067424(21)B2JX23, (01)00884838067424(21)B2VLYV, (01)00884838067424(21)B38WRX, (01)00884838067424(21)B2885B, (01)00884838067424(21)B2M88N, (01)00884838067424(21)B34MFB, (01)00884838067424(21)B2Y9NP, (01)00884838067424(21)B37CZZ, (01)00884838067424(21)B2YBHP, (01)00884838061385(21)B09PPC, (01)00884838061385(21)B0JJR9, (01)00884838067424(21)B2016G, (01)00884838061385(21)B0NM53, (01)00884838061385(21)B07ZMN, (01)00884838061385(21)B0T1D9, (01)00884838067424(21)B2HNMQ, (01)00884838067424(21)B3NTB4, (01)00884838067424(21)B35YCB, (01)00884838067424(21)B3M8K5, (01)00884838067424(21)B3VTKH, (01)00884838067424(21)B29W4H, (01)00884838067424(21)B3KT38, (01)00884838067424(21)B2Y9W4, (01)00884838067424(21)B224VG, (01)00884838067424(21)B3DQFC, (01)00884838067424(21)B2Q8TB, (01)00884838067424(21)B28GZJ, (01)00884838067424(21)B1Y1KN, (01)00884838067424(21)B3M8JM, (01)00884838067424(21)F01BFY, (01)00884838067424(21)B224P8, (01)00884838067424(21)B3MGQ2, (01)00884838067424(21)B28MJ4, (01)00884838067424(21)B28RTL, (01)00884838067424(21)B2XQ1T, (01)00884838067424(21)B3QZ1R, (01)00884838067424(21)B2M84T, (01)00884838067424(21)B224RW, (01)00884838067424(21)F01C44, (01)00884838067424(21)F00BR0, (01)00884838067424(21)B2C4FW, (01)00884838067424(21)B3777H, (01)00884838067424(21)F02T5G, (01)00884838067424(21)B3KHV2, (01)00884838067424(21)B2018Y, (01)00884838067424(21)B3RB2L, (01)00884838067424(21)F01338, (01)00884838067424(21)B3C4PZ, (01)00884838067424(21)B3JWP9, (01)00884838067424(21)B25N0D, (01)00884838067424(21)B3LZ0Q, (01)00884838067424(21)F012L3, (01)00884838067424(21)B1Y18D, (01)00884838067424(21)B2JWW0, (01)00884838067424(21)B23VFZ, (01)00884838067424(21)B3CWQ6, (01)00884838067424(21)B1Y1HR, (01)00884838067424(21)B34JZH, (01)00884838067424(21)B3CM0P, (01)00884838067424(21)B29JJ4, (01)00884838067424(21)B37DDK, (01)00884838067424(21)B2C5JP, (01)00884838067424(21)F01C4C, (01)00884838067424(21)B37D99, (01)00884838067424(21)F03K4B, (01)00884838067424(21)B3RK4B, (01)00884838067424(21)B200XL, (01)00884838067424(21)B3TXH3, (01)00884838067424(21)B2JX1L, (01)00884838067424(21)F04C24, (01)00884838067424(21)B307RM, (01)00884838067424(21)B2YZWK, (01)00884838067424(21)B3F50C, (01)00884838067424(21)B200W2, (01)00884838067424(21)B35YBN, (01)00884838067424(21)B307RD, (01)00884838067424(21)B30V8H, (01)00884838067424(21)B2C4LF, (01)00884838067424(21)B2C3P7, (01)00884838067424(21)B23VDR, (01)00884838067424(21)B2C529, (01)00884838067424(21)B3KHV3, (01)00884838067424(21)B287TP, (01)00884838061385(21)B0Q58D, (01)00884838061385(21)B14YNH, (01)00884838061385(21)B0BP7R, (01)00884838061385(21)B0K5HN, (01)00884838061385(21)B0T41K, (01)00884838067424(21)B25LTY, (01)00884838067424(21)B29VVP, (01)00884838085176(21)B279QK, (01)00884838085176(21)B1MC5Z, (01)00884838085176(21)B1FN91, (01)00884838085176(21)B1MBQK, 010088483808517621B27BF6, (01)00884838085176(21)B1W19Z, (01)00884838085176(21)B1W1BL, (01)00884838085176(21)B1MCBL, (01)00884838085176(21)B1QHPV, (01)00884838085176(21)B1MC33, (01)00884838085176(21)B25WL3, (01)00884838085176(21)B1FN3L, (01)00884838085176(21)B1W1BG, (01)00884838085176(21)B279L4, 010088483808517621B279Z7, (01)00884838072312(21)B1QJ53, (01)00884838072312(21)B25F17, (01)00884838072312(21)B2395Q, (01)00884838085176(21)B1MC3B, (01)00884838072312(21)B23953, 010088483808517621B1W1FP, (01)00884838086555(21)B2C80T, (01)00884838072312(21)B2394F, (01)00884838085176(21)B279T5, (01)00884838085176(21)B1JNKV, 010088483808517621B1QHCV, (01)00884838072312(21)B1XL56, (01)00884838072312(21)B2394T, (01)00884838072312(21)B1XL4D, (01)00884838085176(21)B1MBT1, (01)00884838085176(21)B1QHKW, (01)00884838085176(21)B27B7C, (01)00884838085176(21)B1QHLG, (01)00884838072312(21)B2393M, (01)00884838061828(21)B1FN5R, (01)00884838085176(21)B2Z0T1, (01)00884838068766(21)B1QHKV, (01)00884838061828(21)B1MC27, (01)00884838061828(21)B1FN4V, (01)00884838068766(21)B1QHPC, (01)00884838085176(21)B1MQQG, (01)00884838061828(21)B1MC31, (01)00884838068766(21)B1QHM3, (01)00884838085176(21)B1MBZK, (01)00884838085176(21)B27BGM, (01)00884838085176(21)B279VD, (01)00884838085176(21)B1W1RW, (01)00884838085176(21)B1QHLK, (01)00884838085176(21)B1MBT8, 010088483808517621B1MC98, (01)00884838085176(21)B27B8P, (01)00884838085176(21)B1MC40, (01)00884838085176(21)B1MBTK; Serial No. B36LWB, B2YZPM, B34JQB, F01L9N, B3V8CH, B3LJYB, B2C4FQ, F010MV, B3VGXG, F03968, B31MT5, B28T00, B2C44Y, B3D56M, B22P69, B3Q81Z, B20145, B3R9R3, B3G9N5, F0174Y, B200TW, B224WW, B3C3W7, B2JX46, B2VM4B, B30VBF, B3WD3C, B39XCG, B2L1X5, B2VLYK, B3LZ50, B3V9LJ, B25N1F, B231L5, B31MT1, B2C3W9, F016D1, B22NVD, F008M1, B1XBNC, B30V7Y, B34JXT, B3QQX0, B2JWTF, B1Y1D9, F02QD4, B34T00, F01K6Z, B3P65C, B224KM, B33706, B32B9T, B2ND6N, B39XDX, B2WDTZ, B2HNP4, B2YZT6, B30CJT, B39ZX8, B200T8, B37D0B, B2WZYX, B2JXDC, B2FY26, B34MHH, B2Q8W4, B2XBFY, B2L1W0, B22P40, B2C5P4, B127JJ, B11G3D, B224KD, B0JJLQ, B0NG16, F019T7, B3H966, F01GFM, F0119H, B39FB8, F002CB, B36B5B, B23VFT, F013HC, B2R8T8, B3G8ZY, B2NDGV, B37D8Y, F005XT, B2Y9YX, B3RKBD, B37D2W, F02QD3, B3V9NL, B1XB2Q, B2C43R, B2L1T9, B3Q81N, B37D34, B34JXC, B3M9F3, B2C5FL, B35YBH, B2M84V, F004KL, B3DQCW, F02DPJ, B2C40T, B224RL, B231GL, B3VGXP, B3RJXK, B224JV, F01C47, B3VCQD, B28RPC, B3QR18, F002CD, B20170, F00LD5, B2C449, B34T3Z, B32B77, B2YZXG, B2M78R, B2HN85, B2YZQF, B25M1W, B38WW3, B39XG1, B2L1Y9, B0T4G8, B1XBJZ, B0HNH9, B0WNP3, B12WHD, B0QVLH, B2BBKQ, B28RNX, B3M9CY, B2JWX4, B200R1, B2VLNB, B25N07, B3VGZP, B38WQ2, B3RKB7, B37DL7, B34JQR, B23W05, B3V9FD, F0103N, F014WR, B36LRF, B35YFJ, B307T7, B31MQ3, B3JQTT, B1XB6C, B3F4T5, B39X4R, B3C3PN, B3F508, B3VCQT, F027KD, B20156, B3RB11, F00LDG, B2BBKL, B3R49J, F00PJ0, B23W0X, F016L9, B2C42R, B217CD, B2NDNG, B3F5DY, B3V9JP, B2HN60, B22P38, B2Z0NZ, B27XBQ, B2L1VZ, B224QQ, B2YZQC, B200VX, B2C4XN, B2JX23, B2VLYV, B38WRX, B2885B, B2M88N, B34MFB, B2Y9NP, B37CZZ, B2YBHP, B09PPC, B0JJR9, B2016G, B0NM53, B07ZMN, B0T1D9, B2HNMQ, B3NTB4, B35YCB, B3M8K5, B3VTKH, B29W4H, B3KT38, B2Y9W4, B224VG, B3DQFC, B2Q8TB, B28GZJ, B1Y1KN, B3M8JM, F01BFY, B224P8, B3MGQ2, B28MJ4, B28RTL, B2XQ1T, B3QZ1R, B2M84T, B224RW, F01C44, F00BR0, B2C4FW, B3777H, F02T5G, B3KHV2, B2018Y, B3RB2L, F01338, B3C4PZ, B3JWP9, B25N0D, B3LZ0Q, F012L3, B1Y18D, B2JWW0, B23VFZ, B3CWQ6, B1Y1HR, B34JZH, B3CM0P, B29JJ4, B37DDK, B2C5JP, F01C4C, B37D99, F03K4B, B3RK4B, B200XL, B3TXH3, B2JX1L, F04C24, B307RM, B2YZWK, B3F50C, B200W2, B35YBN, B307RD, B30V8H, B2C4LF, B2C3P7, B23VDR, B2C529, B3KHV3, B287TP, B0Q58D, B14YNH, B0BP7R, B0K5HN, B0T41K, 03DRXN, 03DMNQ, B08G95, 0387T2, B021BX, 03DQ4W, B25LTY, B29VVP, B279QK, B1MC5Z, B1FN91, B1MBQK, B27BF6, B1W19Z, B1W1BL, B1MCBL, B1QHPV, B1MC33, B25WL3, B1FN3L, B1W1BG, B279L4, B279Z7, B1QJ53, B25F17, B2395Q, B1MC3B, B23953, B1W1FP, B2C80T, B2394F, B279T5, B1JNKV, B1QHCV, B1XL56, B2394T, B1XL4D, B1MBT1, B1QHKW, B27B7C, B1QHLG, B2393M, B1FN5R, B2Z0T1, B1QHKV, B1MC27, B1FN4V, B1QHPC, B1MQQG, B1MC31, B1QHM3, B1MBZK, B27BGM, B279VD, B1W1RW, B1QHLK, B1MBT8, B1MC98, B27B8P, B1MC40, B1MBTK.

510(k) numbers

["K030455","K043535","K133833","K081661","K120321"]

PMA numbers

not on file

Product code

ITX

Firm FEI

2518586

Firm city

Reedsville

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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