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FDA (Device enforcement)Recalled 2025-07-03class iii

Philips Ultrasound, Inc: X5-1 Transducer Probe

Hazard

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

Details from the source

Reason for recall: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Distribution: US Nationwide distribution. Quantity: 171,322 units Lot/code info: Model No. 989605400802, 989605438491, 989605353783, 989605427811, 989605353781, 989605412052, 989605455171, 989605431531, 989605412062, 989605466031, 989605409562, 989605414122, 989605412082; UDI: (01)00884838061422(21)B23Y3N, (01)00884838061422(21)B27BYD, (01)00884838061422(21)B2FCRL, (01)00884838061422(21)B32F76, (01)00884838061422(21)B3MTPX, N/A, (01)00884838061422(21)B29NQ7, (01)00884838061422(21)B3214W, (01)00884838061422(21)B3GYYT, (01)00884838061774(21)B1VBR6, N/A, (01)00884838061422(21)B2W4GN, (01)00884838061422(21)F04ZXB, (01)00884838061422(21)F0F732, (01)00884838061774(21)F01CVG, N/A, (01)00884838061422(21)B2F0M1, (01)00884838061422(21)B2MGRL, (01)00884838061422(21)B320V9, (01)00884838061422(21)B3LQXV, (01)00884838061422(21)F04W88, (01)00884838061422(21)F09L1M, (01)00884838061422(21)B3P1B2, (01)00884838061422(21)F0D14W, (01)00884838061422(21)B268JG, (01)00884838061422(21)B27YP4, (01)00884838061422(21)B2XBW5, (01)00884838061422(21)B320LD, (01)00884838061422(21)B3GZ6M, (01)00884838061422(21)B3WK0K, (01)00884838061422(21)F00ZYG, (01)00884838061422(21)F0105H, (01)00884838061422(21)F011ZX, (01)00884838061422(21)F01201, (01)00884838061422(21)F0120G, (01)00884838061422(21)F02DJL, (01)00884838061422(21)F02TM9, (01)00884838061422(21)F037V5, (01)00884838061422(21)F03LCJ, (01)00884838061422(21)F05WFT, (01)00884838061422(21)F0KTJ3, (01)00884838061422(21)F0KTJB, (01)00884838061774(21)B1ZZRQ, 010088483806142221F02C9L, N/A, N/A, (01)00884838061422(21)B2XMJ0, 010088483806142221F01Q

UPC codes

989605400802, 989605438491, 989605353783, 989605427811, 989605353781, 989605412052, 989605455171, 989605431531, 989605412062, 989605466031, 989605409562, 989605414122, 989605412082, 00884838061422, 00884838061774

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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