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Recall Observatory FDA recall evidence

Device product

S7-2t Transducer Probe

Z-2396-2025

July 03, 2025

Class III

Product summary

Firm
Philips Ultrasound, Inc
Event
Event 97217
Status
Ongoing
Classification
Class III
Quantity
171,322 units
Official record key
device-enforcement:Z-2396-2025

Official wording

Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

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.

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    To provide clarification and labelling to define the useful life of ultrasound transducers in the field.