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

Philips Ultrasound, Inc: X11-4t 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. 989605501821; UDI: (01)00884838102729(21)F0JZ1H, (01)00884838102729(21)F0KDBZ, (01)00884838102729(21)F0KL95, (01)00884838102729(21)F0KDC4, (01)00884838102729(21)F0GF3C, (01)00884838102729(21)F0JX4T, (01)00884838102729(21)F0JW38, (01)00884838102729(21)F0JX4N, (01)00884838102729(21)F0JL69, (01)00884838102729(21)F0JW3F, (01)00884838102729(21)F0KL87, (01)00884838102729(21)F0JTZB, (01)00884838102729(21)F0K1V3, (01)00884838102729(21)F0JY4F, (01)00884838102729(21)F0K5PZ, (01)00884838102729(21)F0KRDC, (01)00884838102729(21)F0K5Q0, (01)00884838102729(21)F0K5LG, (01)00884838102729(21)F0KL8H, (01)00884838102729(21)F0JL67, (01)00884838102729(21)F0GXQV, (01)00884838102729(21)F0GZ3K, (01)00884838102729(21)F0GXQ7, (01)00884838102729(21)F0JMYN, (01)00884838102729(21)F0JTZD, (01)00884838102729(21)F0K5LX, (01)00884838102729(21)F0JX4M, 010088483810272921F0GLHY, (01)00884838102729(21)F0HCC8, (01)00884838102729(21)F0JZ1Y, (01)00884838102729(21)F0KL8R, (01)00884838102729(21)F0GZ2V, (01)00884838102729(21)F0H4RH, (01)00884838102729(21)F0H87N, (01)00884838102729(21)F0GC3G, 010088483810272921F0FJ83, (01)00884838102729(21)F0LFHC, (01)00884838102729(21)F0JMYK, (01)00884838102729(21)F0HCC4, (01)00884838102729(21)F0KZ8R, (01)00884838102729(21)F0JTZF, (01)00884838102729(21)F0JW3K, (01)00884838102729(21)F0JX4Y, (01)00884838102729(21)F0JZ1M, 010088483810272921F0FV78, 010088483810272921F0G65V, 010088483810272921F0GC3F, (01)00884838102729(21)F0JL6C, (01)00884838102729(21)F0KHDH, (01)00884838102729(21

UPC codes

989605501821, 00884838102729

Source

Official record: FDA (Device enforcement)

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

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