FDAFDA · Food and drugs·Recall number Z-2067-2025
Philips X8-2t Transducer.
Published July 9, 2025 · Recall initiated: May 28, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Ultrasound transducer devices were refurbished beyond their useful life.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Ultrasound, Inc
- Distributor
- 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
- Model No. 989605455171; UDI: (01)00884838069718(21)B2JH74, (01)00884838069718(21)B29746, (01)00884838069718(21)B1ZGLZ, (01)00884838069718(21)B34TNV, (01)00884838069718(21)B2JJHM, (01)00884838069718(21)B34TLN, (01)00884838069718(21)B2C84F, (01)00884838069718(21)B2FTXW, (01)00884838069718(21)B24WXT, (01)00884838069718(21)B2T8C5, (01)00884838069718(21)B2JJGX, (01)00884838069718(21)B2T86R, (01)00884838069718(21)B2C8L5, (01)00884838069718(21)B38VJZ, (01)00884838069718(21)B2JGTC, (01)00884838069718(21)B2VQFK, (01)00884838069718(21)B2XD5P, (01)00884838069718(21)B2B8WQ, (01)00884838069718(21)B2JGNL, (01)00884838069718(21)B274VJ, (01)00884838069718(21)B2BN6Q, (01)00884838069718(21)B1ZGLQ, (01)00884838069718(21)B2NMKC, (01)00884838069718(21)B2JJD0, (01)00884838069718(21)B24WRV, (01)00884838069718(21)B39B8M, (01)00884838069718(21)B34Z1Y, (01)00884838061668(21)B1ZH9T, (01)00884838069718(21)B2VQNN, (01)00884838069718(21)B2FVW4, (01)00884838069718(21)B241C7, (01)00884838069718(21)B2JJPB, (01)00884838069718(21)B28JKF, (01)00884838069718(21)B2T85C, (01)00884838069718(21)B2FDPK, (01)00884838069718(21)B2JHK4, (01)00884838069718(21)B2GCL7, (01)00884838069718(21)B2JJBM, (01)00884838069718(21)B2XDJW, (01)00884838069718(21)B3NCQK, (01)00884838069718(21)B3CN4X, (01)00884838069718(21)B2NMF2, (01)00884838069718(21)B2JH9N, (01)00884838069718(21)B2FT86, (01)00884838069718(21)B2CGH0, (01)00884838069718(21)B25DGP, (01)00884838069718(21)B34Z7H, (01)00884838069718(21)B2B7HL, (01)00884838069718(21)B29MMT, (01)00884838069718(21)B3DRDM, (01)00884838069718(21)B24VLY, (01)00884838069718(21)B2JGL2, (01)00884838069718(21)B20TVJ, (01)00884838069718(21)B2JJJG, (01)00884838069718(21)B1TZBK, (01)00884838069718(21)B2GFN0, (01)00884838069718(21)B26JZZ, (01)00884838069718(21)B2B8BD, (01)00884838069718(21)B2T86T, (01)00884838069718(21)B2XD25, (01)00884838069718(21)B2DKRC, (01)00884838069718(21)B2XDJJ, (01)00884838069718(21)B2JJCY, (01)00884838069718(21)B2JHL3, (01)00884838069718(21)B3DT30, (01)00884838069718(21)B2417B, (01)00884838069718(21)B2XCLV, (01)00884838069718(21)B2XD3F, (01)00884838069718(21)B2C6NX, (01)00884838069718(21)B2BNB6, (01)00884838069718(21)B2JJ75, (01)00884838069718(21)B2T848, (01)00884838069718(21)B24VZX, (01)00884838069718(21)B2B45V, (01)00884838069718(21)B2B6K7, (01)00884838069718(21)B2FC75, (01)00884838069718(21)B2T85D, (01)00884838069718(21)B2XDDF, (01)00884838069718(21)B3M1KH, (01)00884838069718(21)B20TT1, (01)00884838069718(21)B2C6TL, (01)00884838069718(21)B2JJ4P, (01)00884838069718(21)B2CHG2, (01)00884838069718(21)B2B8X3, (01)00884838069718(21)B24VG2, (01)00884838069718(21)B2XD7X, (01)00884838069718(21)B2JGLB, (01)00884838069718(21)B2973L, (01)00884838069718(21)B2VQFV, (01)00884838069718(21)B2T86G, (01)00884838069718(21)B2VQFH, (01)00884838069718(21)B38VRV, (01)00884838069718(21)B2JJ23, (01)00884838069718(21)B2D28N, (01)00884838069718(21)B38VJ1, (01)00884838069718(21)B2JGPT, (01)00884838069718(21)B1ZH2N, (01)00884838069718(21)B3DR7G, (01)00884838069718(21)B2VQTW, (01)00884838069718(21)B25DM0, (01)00884838069718(21)B2XCZC, (01)00884838069718(21)B2CHL0, (01)00884838069718(21)B2BN72, (01)00884838069718(21)B2JGQB, (01)00884838069718(21)B2GCGR, (01)00884838069718(21)B28HLG, (01)00884838069718(21)B24VJ7, (01)00884838069718(21)B2JJ12, (01)00884838069718(21)B34YY3, (01)00884838069718(21)B24VBJ, (01)00884838069718(21)B2JJQV, (01)00884838069718(21)B2T86M, (01)00884838069718(21)B22R14, (01)00884838069718(21)B2FVGC, (01)00884838069718(21)B2JHLH, (01)00884838069718(21)B1ZGRY, (01)00884838069718(21)B28JKK, (01)00884838069718(21)B2DYC0, (01)00884838069718(21)B2XCFW, (01)00884838069718(21)B29ML2, (01)00884838069718(21)B29MMW, (01)00884838069718(21)B2XCXP, (01)00884838069718(21)B2B4YR, (01)00884838069718(21)B2T8D1, (01)00884838069718(21)B3J47P, (01)00884838069718(21)B3DRR6, (01)00884838069718(21)B2JGMW, (01)00884838069718(21)B3CN34, (01)00884838069718(21)B1VLPX, (01)00884838069718(21)B25D9W, (01)00884838069718(21)B293NH, (01)00884838069718(21)B2G7DD, (01)0088483
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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