Z-2059-2025 Class II Ongoing

Recalled by Philips Ultrasound, Inc — Reedsville, PA

Recall Details

Product Type
Devices
Report Date
July 9, 2025
Initiation Date
May 28, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,230 units

Product Description

Philips S7-2 Transducer.

Reason for Recall

Ultrasound transducer devices were refurbished beyond their useful life.

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.

Code Information

Model No. 989605440772, 989605440771, 989803002261; UDI: (01)00884838067646(21)032MLP, (01)00884838067646(21)B1MMJ8, (01)00884838067646(21)02M708, (01)00884838067646(21)02Q7XJ, (01)00884838067646(21)03CX7R, (01)00884838067646(21)031FV7, (01)00884838067646(21)03C7PW, (01)00884838067646(21)02MJXP, (01)00884838067646(21)02MD57, (01)00884838067646(21)B07FCJ, (01)00884838067646(21)037HLQ, (01)00884838067646(21)B0D3FH, (01)00884838067646(21)031CCH, (01)00884838067646(21)B0M2ZJ, (01)00884838067646(21)039TX5, (01)00884838067646(21)02P5NP, (01)00884838067646(21)031KD1, (01)00884838067646(21)039J9F, (01)00884838067646(21)B0X1K1, (01)00884838067646(21)B0X19Q, (01)00884838067646(21)B04LKL, (01)00884838067646(21)B02VFV, (01)00884838067646(21)03C76J, (01)00884838067646(21)0377MN, (01)00884838067646(21)02Q81T, (01)00884838067646(21)032KCR, (01)00884838067646(21)037HKZ, (01)00884838067646(21)02YH4N, (01)00884838067646(21)02ZTV7, (01)00884838067646(21)B03N8W, (01)00884838067646(21)B0JF6L, (01)00884838067646(21)02VPXJ, (01)00884838067646(21)02MJ8V, (01)00884838067646(21)039GDN, (01)00884838067646(21)B02VM7, (01)00884838067646(21)03G2YM, (01)00884838067646(21)03C229, (01)00884838067646(21)03408Y, (01)00884838067646(21)B14389, (01)00884838067646(21)037FG5, (01)00884838067646(21)03C22H, (01)00884838067646(21)0360L6, (01)00884838067646(21)02VYX4, (01)00884838067646(21)038ND8, (01)00884838067646(21)03CTXP, (01)00884838067646(21)038HV0, (01)00884838067646(21)03H8P2, (01)00884838067646(21)B0D3CJ, (01)00884838067646(21)02M8VJ, (01)00884838067646(21)032KM9, (01)00884838067646(21)02ZXMD, (01)00884838067646(21)032ML8, (01)00884838067646(21)B0M2Y7, (01)00884838067646(21)03G4H4, (01)00884838067646(21)B04LHQ, (01)00884838067646(21)B03N5M, (01)00884838067646(21)039Q24, (01)00884838067646(21)035ZRG, (01)00884838067646(21)B0D3K6, (01)00884838067646(21)03C7QF, (01)00884838067646(21)02QDML, (01)00884838067646(21)035YQ7, (01)00884838067646(21)03FFKF, (01)00884838067646(21)033XDQ, (01)00884838067646(21)031L1D, (01)00884838067646(21)B07F16, (01)00884838067646(21)B0D3FX, (01)00884838067646(21)B04LJ8, (01)00884838067646(21)032F6B, (01)00884838067646(21)B0M2Z3, (01)00884838067646(21)03CVTD, (01)00884838067646(21)02YCGM, (01)00884838067646(21)B0D3B1, (01)00884838067646(21)031HNX, (01)00884838067646(21)02VPXW, (01)00884838067646(21)031HNP, (01)00884838067646(21)02DL8V, (01)00884838067646(21)B09QBH, (01)00884838067646(21)03GZ16, (01)00884838067646(21)03CVV6, (01)00884838067646(21)02VRXY, (01)00884838067646(21)039T16, (01)00884838067646(21)0377MB, (01)00884838067646(21)02WHJ9, (01)00884838067646(21)03C3CP, (01)00884838067646(21)02WMBT, (01)00884838067646(21)B199DF, (01)00884838067646(21)B0M2QB, (01)00884838067646(21)B02VG4, (01)00884838067646(21)02YGGH, (01)00884838067646(21)02WNQ3, (01)00884838067646(21)032KMG, (01)00884838067646(21)03G4Q0, (01)00884838067646(21)02YCGW, (01)00884838067646(21)031HPK, (01)00884838067646(21)0379CF, (01)00884838067646(21)02VN41, (01)00884838067646(21)B09QF9, (01)00884838067646(21)B02VR5, (01)00884838067646(21)02QGLB, (01)00884838067646(21)02DD8X, (01)00884838067646(21)B04LTF, (01)00884838067646(21)02VXKB, (01)00884838067646(21)B02VGP, (01)00884838067646(21)03G2YR, (01)00884838067646(21)B07FC1, (01)00884838067646(21)B09Q99, (01)00884838067646(21)037CHP, (01)00884838067646(21)B0M31B, (01)00884838067646(21)037F54, (01)00884838067646(21)03436T, (01)00884838067646(21)B0M2XV, (01)00884838067646(21)02PF3Y, (01)00884838067646(21)037KVL, (01)00884838067646(21)B03N6R, (01)00884838067646(21)B04LVL, (01)00884838067646(21)02PH28; Serial No. 032MLP, B1MMJ8, 02M708, 02Q7XJ, 03CX7R, 031FV7, 03CVTN, 03C7PW, 02MJXP, 038D0N, 02MD57, B07FCJ, 02ZTTZ, 037HLQ, B0D3FH, 031CCH, B0M2ZJ, 039TX5, 02P5NP, 031KD1, 039J9F, B0X1K1, B0X19Q, B04LKL, B02VFV, 02YH45, 03C76J, 0377MN, 02Q81T, 032KCR, 037HKZ, 02YH4N, 03C371, 02ZTV7, B03N8W, B0JF6L, 032MYK, 02VPXJ, 02MJ8V, 039GDN, 032FKQ, 037HL5, B02VM7, 03G2YM, 03C229, 03408Y, 037HKT, B14389, 037FG5, 03C22H, 0360L6, 02VYX4, 038ND8, 03CTXP, 038HV0, 035P7T, 03H8P2, 0360LW, 033Y8N, B0D3CJ, 02M8VJ, 032KM9, 02ZXMD, 032ML8, 032N5N, B0M2Y7, 03G4H4, B04LHQ, B03N5M, 039Q24, 035ZRG, B0D3K6, 03C7QF, 02QDML, 035YQ7, 032MLH, 03FFKF, 033XDQ, 031L1D, B07F16, 033XDL, B0D3FX, 03CTX0, 02QLMH, B04LJ8, 032F6B, B0M2Z3, 03CVTD, 02YCGM, B0D3B1, 031HNX, 02VPXW, 039GFP, 031HNP, 02DL8V, 037F67, B09QBH, 032G15, 03C9QV, 0343ZP, 03GZ16, 03CVV6, 02VRXY, B02VHC, 039T16, 0377MB, 02WHJ9, 03C3CP, 02WMBT, B199DF, 03CQVP, B0M2QB, B02VG4, 02YGGH, 02WNQ3, 032KMG, 02Q89Q, 03G4Q0, 02YCGW, 031HPK, 0379CF, 03C3QH, 02VN41, B09QF9, B02VR5, 02QGLB, 02DD8X, B04LTF, 02VXKB, B02VGP, 03G2YR, 02MBBM, B07FC1, B09Q99, 037CHP, 03CVTG, B0M31B, 02JQ96, 037F54, 03436T, B0M2XV, 034403, 02PF3Y, 030225, 037KVL, 02Y7WM, B03N6R, B04LVL, 02PH28.