S7-2t Transducer Probe
FDA Recall #Z-2396-2025 — Class III — July 3, 2025
Product Description
S7-2t Transducer Probe
Reason for Recall
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Recalling Firm
Philips Ultrasound, Inc — Reedsville, PA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
171,322 units
Distribution
US Nationwide distribution.
Code Information
Model No. 21778A, 989605440772; UDI: (01)00884838067646(21)B199HC, (01)00884838067646(21)B20ZV2, (01)00884838067646(21)B1MMLZ, (01)00884838067646(21)B04LQ0, (01)00884838067646(21)B20ZW6, (01)00884838067646(21)B0X1HK, (01)00884838067646(21)B199CY, (01)00884838067646(21)B02VM7, (01)00884838067646(21)B0X1KX, (01)00884838067646(21)B1MMLD, (01)00884838067646(21)B20ZT7, (01)00884838067646(21)B1MMK0, (01)00884838067646(21)B2JGW0, (01)00884838067646(21)B20ZVC, (01)00884838067646(21)B199DH, (01)00884838067646(21)B1MMJM, (01)00884838067646(21)B1MMH3, (01)00884838067646(21)B20ZWB, (01)00884838067646(21)B1MMLY, (01)00884838067646(21)B14389, (01)00884838067646(21)B1MMH4, (01)00884838067646(21)B20ZWK, (01)00884838067646(21)B1MMJZ, (01)00884838067646(21)B1MMKN, (01)00884838067646(21)B20ZT4, (01)00884838067646(21)B20ZWY, (01)00884838067646(21)B2JJ40, (01)00884838067646(21)B2JGLK, (01)00884838067646(21)B0X1LJ, (01)00884838067646(21)B1MMM4, (01)00884838067646(21)B20ZW0, (01)00884838067646(21)B199DG, (01)00884838067646(21)B2HX2Y, (01)00884838067646(21)B1MMJ5, (01)00884838067646(21)B1999W, (01)00884838067646(21)B0D3CJ, (01)00884838067646(21)B199BH, (01)00884838067646(21)B199B7, (01)00884838067646(21)B1436D, (01)00884838067646(21)B20ZWC, (01)00884838067646(21)B1MMK5, (01)00884838067646(21)B0X1K7, (01)00884838067646(21)B0M32V, (01)00884838067646(21)B199D5, (01)00884838067646(21)B20ZW8, (01)00884838067646(21)B199DB, (01)00884838067646(21)B1439X, (01)00884838067646(21)B0M2Y7, (01)00884838067646(21)B1MMJV, (01)00884838067646(21)B04LHQ, (01)00884838067646(21)B199GK, (01)00884838067646(21)B03N5M, (01)00884838067646(21)B1MML9, (01)00884838067646(21)B0X1DG, (01)00884838067646(21)B20ZTY, (01)00884838067646(21)B0X1CV, (01)00884838067646(21)B1MML7, (01)00884838067646(21)B20ZVF, (01)00884838067646(21)B2100C, (01)00884838067646(21)B21075, (01)00884838067646(21)B1MML6, (01)00884838067646(21)B20ZX1, (01)00884838067646(21)B1MMJB, (01)00884838067646(21)B1MMKZ, (01)00884838067646(21)B1436N, (01)00884838067646(21)B1MMM8, (01)00884838067646(21)B1MMHN, (01)00884838067646(21)B199CJ, (01)00884838067646(21)B1MMLP, (01)00884838067646(21)B20ZT9, (01)00884838067646(21)B199D0, (01)00884838067646(21)B0X1GY, (01)00884838067646(21)B199DQ, (01)00884838067646(21)B1MMHQ, (01)00884838067646(21)B0D3B1, (01)00884838067646(21)B1MMK7, (01)00884838067646(21)B2100L, (01)00884838067646(21)B20ZVK, (01)00884838067646(21)B09QBH, (01)00884838067646(21)B20ZT3, (01)00884838067646(21)B2109D, (01)00884838067646(21)B199CZ, (01)00884838067646(21)B2JJ4C, (01)00884838067646(21)B199DF, (01)00884838067646(21)B0M2XH, (01)00884838067646(21)B20ZWT, (01)00884838067646(21)B20ZWV, (01)00884838067646(21)B1MMMB, (01)00884838067646(21)B1MMJ4, (01)00884838067646(21)B1MMLF, (01)00884838067646(21)B2100H, (01)00884838067646(21)B1MMMN, (01)00884838067646(21)B199C7, (01)00884838067646(21)B0M2XV, (01)00884838067646(21)B1MMK6, (01)00884838067646(21)B2HXCQ, (01)00884838067646(21)B14388, (01)00884838067646(21)B20ZTR, (01)00884838067646(21)B02VR5, (01)00884838067646(21)B1999K, (01)00884838067646(21)B20ZVR, (01)00884838067646(21)B04LTF, (01)00884838067646(21)B199DP, (01)00884838067646(21)B2JJH5, (01)00884838067646(21)B2104V, (01)00884838067646(21)B20ZVT, (01)00884838067646(21)B0M2V5, (01)00884838067646(21)B2JGVW, (01)00884838067646(21)B1MMHT, (01)00884838067646(21)B20ZTV, (01)00884838067646(21)B20ZX6, (01)00884838067646(21)B1439V, (01)00884838067646(21)B1MMLW; Serial No. B04LH4, B199HC, 02VPXJ, B20ZV2, B1MMLZ, 02MJ8V, B0X1K5, 039GDN, B04LQ0, B20ZW6, B0X1HK, 035PX3, B19998, 032FKQ, 037HL5, B199CY, B02VM7, B0X1KX, B1MMLD, B20ZT7, B1438Z, 02QFTZ, 03G2YM, B1MMK0, B0X1F3, B2JGW0, 03C229, 02GQW5, B20ZVC, 03408Y, B199DH, 035P86, 037HKT, B1MMJM, B1MMH3, B20ZWB, B199FL, B199G9, B199GQ, B1MMLY, B14389, B1MMH4, 03H8J8, B20ZWK, B1MMJZ, B1MMKN, 039JWR, B20ZT4, 031GMK, 039JWM, 037FG5, 03C22H, 031LC9, 0360L6, B1436K, B20ZWY, B2JJ40, 02YGGY, 02VYX4, B2JGLK, B0X1LJ, B1MMGZ, B1MMM4, B199GX, B20ZW0, 038ND8, B0M2T6, B199GV, 03CTXP, B199DG, 038HV0, B0D386, B199GP, B2HX2Y, 035P7T, B199H0, B1MMJ5, 03H8P2, B1999W, B199GF, B199BY, 0360LW, 033Y8N, B0D3CJ, B199BH, B199HB, B199B7, 02Y86M, 02M8VJ, B199CQ, B1436D, B199DJ, 032KM9, B02VHW, B0JF9V, B199GJ, B20ZWC, 02ZXMD, B1MMK5, B0X1K7, 038D09, B0M32V, B199D5, B199GG, B20ZW8, 02WM2J, 032ML8, B199DB, B1439X, 032N5N, B143BH, B1437Q, B0M2Y7, B1MMJV, 03G3J5, 03G4H4, B04LHQ, B199GK, B03N5M, B1MML9, 039Q24, B0X1DG, B20ZTY, B0X1CV, B1MML7, 02ZZ0F, 032KCJ, B20ZVF, 02YG6J, B2100C, 035ZRG, B21075, B1MML6, B20ZX1, B1MMJB, 02QDML, B1MMKZ, B1436N, B1MMM8, B199HZ, B1MMHN, B199CJ, 035YQ7, B1MMLP, B20ZT9, B199D0, 02WHB8, B199FW, 032MLH, B0X1GY, 032F6B, B09Q69, B199DQ, B1MMHQ, B1999M, 03CVTD, B0D3B1, 02YCGM, 031HNX, B1999F, B1MMK7, B2100L, 039GFP, B20ZVK, 031HNP, 02DL8V, B02VPG, B09QBH, 037F67, B20ZT3, 03GZ16, B2109D, 03CVV6, B199CZ, B02VHC, 0377MB, 02WHJ9, B0X1D2, B199C3, 03C3CP, 02WMD3, B2JJ4C, 02WMBT, B199DF, B0M2XH, B20ZWT, B20ZWV, B1MMMB, B09QFM, B02VKC, 03CQVP, B1MMJ4, B0X1B6, B0JF6H, B1MMLF, 02WNQ3, 039GD0, B2100H, B1MMMN, B199C7, B07FCC, B199C6, 02Q89Q, B0JFDZ, B0M2XV, B1MMK6, B2HXCQ, B14388, B0D3FW, B20ZTR, B0M30X, B02VR5, 02QGLB, B1999K, B199H5, B20ZVR, B04LTF, B199DP, B2JJH5, B199DR, B14390, 02MBBM, B2104V, B20ZVT, B199DW, B0M2V5, B2JGVW, B1MMHT, 03CVTG, 02JQ96, B199CB, 03436T, B20ZTV, B20ZX6, B1439V, B1MMLW, B199CH, B0X1JJ, 02PH28, 030225, 034530.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated