FDAClass IIJuly 9, 2025

Philips 3D9-3v Transducer recall

Philips 3D9-3v Transducer.

Why was Philips 3D9-3v Transducer recalled?

Ultrasound transducer devices were refurbished beyond their useful life.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model No. 989605395622, 989605415032, 989605440832, 989605440831, 989605395622 , 989605325181; UDI: (01)00884838061545(21)B0D9FJ, (01)00884838061545(21)B10HWZ, (01)00884838061545(21)B1CQY1, (01)00884838061453(21)B13DR6, (01)00884838061545(21)B1C54Z, (01)00884838061545(21)B1MKLW, (01)00884838061545(21)B1MQGQ, (01)00884838061545(21)B1KWYY, (01)00884838061545(21)B1712M, (01)00884838061545(21)B1M9ZT, (01)00884838061545(21)B1DTRL, (01)00884838061545(21)B1K7BL, (01)00884838061545(21)B1RY9G, (01)00884838061453(21)B0T4K5, (01)00884838061545(21)B0T4K9, (01)00884838061545(21)B0TVWK, (01)00884838061545(21)B0PV0C, (01)00884838061545(21)B1301P, (01)00884838061545(21)B1MQGL, (01)00884838067707(21)036WF9, (01)00884838061545(21)B1LY5T, (01)00884838061545(21)B15F9B, (01)00884838061545(21)B15M6F, (01)00884838061545(21)B0X3K9, (01)00884838061453(21)B0LFYH, (01)00884838061453(21)B0LG5D, (01)00884838061545(21)B1TJB5, (01)00884838061545(21)B18NV8, (01)00884838061545(21)B1F54X, (01)00884838067707(21)B1LY5X, (01)00884838061545(21)B1VR93, (01)00884838061453(21)B0KH69, (01)00884838061545(21)B1VPLF, (01)00884838061545(21)B2BMFY, (01)00884838061545(21)B0R10J, (01)00884838061545(21)B14W77, (01)00884838061545(21)B176PT, (01)00884838061453(21)B0NFZD, (01)00884838061545(21)B0T4K4, (01)00884838061545(21)B0J7V5, (01)00884838061545(21)B0R15J, (01)00884838061545(21)B1GJ9L, (01)00884838061545(21)B0WH4P, (01)00884838061453(21)B0LWCV, (01)00884838067707(21)03BMY9, (01)00884838067707(21)B05DJQ, (01)00884838067707(21)0390F5, (01)00884838067707(21)03DWM8, (01)00884838067707(21)B1F5H4, (01)00884838067707(21)038ZPP, (01)00884838067707(21)0366Q8, (01)00884838067707(21)02WBN2, (01)00884838061545(21)B23M54, (01)00884838067707(21)03GC8Q, (01)00884838067707(21)0334YJ, (01)00884838067707(21)03CB7H, (01)00884838067707(21)02ZQPT, (01)00884838067707(21)033QRP, (01)00884838067707(21)035HWH, (01)00884838067707(21)03DWM9, (01)00884838067707(21)02Y4D4, (01)00884838067707(21)0394TC, (01)00884838067707(21)0372QB, (01)00884838067707(21)B1VQ5W, (01)00884838061453(21)B13K2P, (01)00884838067707(21)033G84, (01)00884838067707(21)02W7LR, (01)00884838067707(21)036GBP, (01)00884838067707(21)03BMZP, (01)00884838067707(21)02V8H4, (01)00884838067707(21)02VLBF, (01)00884838067707(21)B01T8Z, (01)00884838067707(21)031P2Y, (01)00884838067707(21)B02NYN, (01)00884838067707(21)02Z6TY, (01)00884838067707(21)030G4C, (01)00884838067707(21)03FTTN, (01)00884838067707(21)038ZZB, (01)00884838067707(21)036RCX, (01)00884838061545(21)B0QL9Z, (01)00884838067707(21)030XZN, (01)00884838067707(21)037RZP, (01)00884838067707(21)B11BVR, (01)00884838067707(21)0393NG, (01)00884838067707(21)B00Q9F, (01)00884838067707(21)0323K1, (01)00884838061453(21)B13DMR, (01)00884838061453(21)B0LG1B, (01)00884838067707(21)037Q39, (01)00884838067707(21)B1PL0J, (01)00884838067707(21)03BT5F, (01)00884838061545(21)B0R2YM, (01)00884838061453(21)B142NX, (01)00884838067707(21)B00VCH, (01)00884838067707(21)03369B, (01)00884838061453(21)B0QH8T, (01)00884838067707(21)03201R, (01)00884838067707(21)036FJ5, (01)00884838061545(21)B0QM5Y, (01)00884838067707(21)B03JR3, (01)00884838061545(21)B24X4B, (01)00884838067707(21)0394Z2, (01)00884838067707(21)02TW66; Serial No. B0D9FJ, B10HWZ, B1CQY1, B13DR6, B1C54Z, B1MKLW, B1MQGQ, B1KWYY, B1712M, B1M9ZT, B1DTRL, B1K7BL, B1RY9G, B0T4K5, B0T4K9, B0TVWK, B0PV0C, B1301P, B1MQGL, 036WF9, B1LY5T, B15F9B, B15M6F, B0X3K9, B0LFYH, B0LG5D, B1TJB5, B18NV8, B1F54X, B1LY5X, B1VR93, B0KH69, B1VPLF, B2BMFY, B0R10J, B14W77, B176PT, B0NFZD, B0T4K4, B0J7V5, B0R15J, B1GJ9L, B0WH4P, B0LWCV, 036RDD, 03BMY9, B05DJQ, 0390F5, 03DWM8, B1F5H4, 038ZPP, 0366Q8, 02WBN2, B23M54, 03GC8Q, 02QPN8, 02XWQY, 0334YJ, 03CB7H, 02ZQPT, 033QRP, 035HWH, 03DWM9, 02Y4D4, 0394TC, 0372QB, B1VQ5W, B13K2P, 033G84, 02W7LR, 02Z2VX, 036GBP, 03BMZP, 02V8H4, 02VLBF, B01T8Z, 031P2Y, 02LYV3, B02NYN, 02Z6TY, 030G4C, 03673G, 03FTTN, 034GJZ, 02W497, 038ZZB, 036RCX, B0QL9Z, 030XZN, 037RZP, B11BVR, 0393NG, B00Q9F, 0323K1, B13DMR, B0LG1B, 037Q39, B1PL0J, 03BT5F, B0R2YM, B142NX, B00VCH, 03369B, B0QH8T, 03201R, 036FJ5, B0QM5Y, B03JR3, B24X4B, 0394Z2, 031318, 0366DL, 02TW66, 02WBMV.

Product
Philips 3D9-3v Transducer.
Recalling firm
Philips Ultrasound, Inc
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.
Recall date
July 9, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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