United StatesPhilips 3D6-2 Ultrasound Transducer and ten other Philips ultrasound transducer models — including C9-4, L12-5, L17-5, Mini Multi TEE, OMNI II TEE, OMNI III TEE, S4-1, S5-2, X3-1 and X7-2 — with the listed model numbers, UDIs and serial numbers distributed nationwide in the U.S. are affected. They were recalled to provide clarification and labeling to define the useful life of ultrasound transducers in the field.
What's being recalled
Philips 3D6-2 Ultrasound Transducer
Philips C9-4 Ultrasound Transducer
Philips L12-5 Ultrasound Transducer
Philips L17-5 Ultrasound Transducer
Philips Mini Multi TEE Ultrasound Transducer
Philips OMNI II TEE Ultrasound Transducer
Philips OMNI III TEE Ultrasound Transducer
Philips S4-1 Ultrasound Transducer
Philips S5-2 Ultrasound Transducer
Philips X3-1 Ultrasound Transducer
Philips X7-2 Ultrasound Transducer
Recalling firm: Philips Ultrasound, Inc, Reedsville, PA, United States.
How to identify it
Model No. 989605326521, 989605440872, 989605440871; UDI: (01)00884838067714(21)02Q19C, (01)00884838067714(21)02VF0G, (01)00884838067714(21)02DNKX, (01)00884838067714(21)02BXT7, (01)00884838067714(21)02TWD3, (01)00884838067714(21)02RRQX, (01)00884838067714(21)02HD9F; Serial No. 02V8MV, 02Q19C, 02DNGH, 02TWL6, 02P2LF, 031XK6, 02VF0G, 02HJ9Q, 02DNKX, 02BXT7, 02VHQZ, 02TWD3, 02NDCL, 02CBD4, 02RRQX, 02KWQ9, 02HD9F. Model No. 989605365021; UDI: N/A; Serial No. 033DZ4. Model No. 989605412401, 989605387311, 989605418552, 989605408173, 989605438481, 989605420231; UDI: (01)00884838067851(21)B27H7T, (01)00884838067974(21)B0B0B1, (01)00884838067851(21)B16RRG, (01)00884838067974(21)B0HWBM, (01)00884838067974(21)B0B39M, (01)00884838067851(21)B1N2FG, (01)00884838067851(21)B1DD6B, (01)00884838067851(21)B27GVB, (01)00884838067851(21)B27RQ7, (01)00884838067851(21)B1WT18, (01)00884838067851(21)B1N1JB; Serial No. B107H4, B106RJ, B02RKJ, B0PXC9, B03JZF, B107JF, B27H7T, B0B0B1, B106XL, B10CF6, B14HHX, B10BZF, B04PTM, B16RRG, 0392R5, B1JPC9, B1JQ8W, B0HWBM, B0B39M, B0XK56, B16L5T, B10BQ3, B0J9Q6, B106DF, B105C1, B1N2FG, B10CTM, B01QKF, B10C67, B0FD7B, B0M21H, B0P7ZP, B1DD6B, B0F6F2, B27GVB, B27RQ7, B14CBD, B14J0X, B1WT18, B1N1JB. Model No. 989605366371, 989605388061; UDI: N/A; Serial No. 03228X, 03360Q. Model No. 989605439241, 989605439242, 21381A; UDI: (01)00884838067547(21)B093BQ, (01)00884838067547(21)B0988T, (01)00884838067547(21)02P6MY, (01)00884838067547(21)039M2Q, (01)00884838067547(21)0319CQ, (01)00884838067547(21)B01639; Serial No. 02GXR0, B093BQ, B0988T, 02P6MY, 039M2Q, 0341YT, 0319CQ, 028NZW, 02H0L8, B01639, 039M2M. Model No. 989605440792; UDI: (01)00884838067660(21)02P8MV; Serial No. 02P8MV, 02MH3J. Model No. 989605440701, 989605440702, 989605440772, 989803001561; UDI: (01)00884838067585(21)02ZTTT, (01)00884838067585(21)B0X7MD, (01)00884838067585(21)02VWNV, (01)00884838067585(21)02JQPG, (01)00884838067585(21)02PCMT, (01)00884838067585(21)0341PG, (01)00884838067585(21)02QLMQ…
The hazard
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)